Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04317326
Other study ID # PI19/00955
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2023
Est. completion date December 2029

Study information

Verified date May 2023
Source Sociedad Española de Neumología y Cirugía Torácica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.


Description:

Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in obesity hypoventilation syndrome (OHS) after an episode of acute-on-chronic hypercapnic respiratory failure. The main outcome will be a composite that includes hospital resource utilization (hospital and ICU admissions and emergency department visits for any cause) and all-cause mortality. Key secondary outcomes will include incident cardiovascular events (new hypertension diagnosis or initiation of anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or unstable angina, percutaneous coronary interventions, nonfatal stroke or transient ischemic attack or for acute heart failure episode, and cardiovascular death), blood pressure, arterial blood gases, clinical symptoms and quality of life. Second phase (long-term): Evaluate the long-term efficacy (36 months) of manually titrated NIV treatment versus manually titrated CPAP treatment in OHS after 3 months of an episode of acute-on-chronic hypercapnic respiratory failure, with a composite outcome of hospital resource utilization (hospital and ICU admissions, emergency department visits) and all-cause mortality analyzed as the primary outcome. Incident cardiovascular events, blood pressure, arterial blood gases, clinical symptoms and quality of life will be the main secondary outcomes. Methods: Prospective, multinational, randomized open-label controlled trial with two parallel arms: 1,110 hospitalized patients with newly diagnosed OHS with acute-on-chronic hypercapnic respiratory failure treated with invasive or noninvasive mechanical ventilation who survive hospitalization and available for hospital discharge will be randomized to either automatically adjusted NIV (555 patients) or "life style modifications" (555 patients) for three months. Subsequently, both automatically adjusted NIV and "life style modifications" arms will be re-randomized to polysomnographically adjusted CPAP or to polysomnographically adjusted NIV groups to complete 36 months of follow up. The first phase of the proposal is a superiority study and the second phase is a non-inferiority study. The primary outcome and its components will be analyzed by a mixed-effects model with negative binomial. A mixed-effects Cox model will be used for hospital resource utilization, new cardiovascular events and overall survival. Other secondary outcomes such as repeated measures derived from the arterial blood gases (i.e. PaCO2, PaO2, pH, calculated bicarbonate), blood pressure, health-related quality of life tests and Epworth Sleepiness Scale during the follow-up will be analyzed by a linear mixed-effects model.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2029
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. º.- Patient between 18 and 85 years old. 2. º.- With diagnosis of OHS (according to Obesity (BMI =30 kg/m2) and Hypercapnic respiratory failure (PaCO2 =45 mmHg at hospital discharge) not secondary to other causes. 3. º - Hospitalized for an episode of acute-on-chronic hypercapnic respiratory failure, receiving hospital therapy with invasive or noninvasive ventilation, and just deemed stable for home discharge." 4. º.- No NIV or CPAP home therapy in the last 6 months[*]. 5. º.- Being able to tolerate and correctly execute a 15-minute test with automatic NIV (AVAPS-AE) and another 15-minute test with fixed CPAP treatments during wakefulness. 6. º.- Providing informed consent (dated and signed). [*] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy. Inclusion criteria for the second phase of the study: 1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days). Exclusion Criteria: Exclusion criteria for the first phase of the study: 1. º.- With moderate or severe chronic obstructive pulmonary disease (FEV1<70% of predicted when FEV1/FVC is below 70%). 2. º.- With neuromuscular disease, thoracic wall or metabolic disease that may cause diurnal hypercapnia. 3. º.- Inability to maintain a patent airway or adequately clear secretions. 4. º.- With bullous lung disease or with pneumothorax. 5. º.- With bypassed upper airway (i.e. endotracheal tube or tracheostomy). 6. º.- With anatomical abnormalities of the craniofacial structure leading to cerebral spinal fluid leaks, abnormalities of the cribriform plate, and/or pneumocephalus. 7. º.- At risk for aspiration of gastric contents. 8. º.- Diagnosed with acute sinusitis or otitis media. 9. º.- With active hemoptysis or epistaxis if presenting a risk of causing pulmonary aspiration of blood. 10. º.- With symptomatic hypotension. 11. º.- With clinical diagnosis of narcolepsy or restless leg syndrome. 12. º.- Psycho-physical incapacity to complete questionnaires. 13. º.- With diagnosis of chronic illness that might interfere the evaluation using quality of life questionnaires (neoplasia, severe chronic pain of any type, and any other severe chronic debilitating illness). 14. º.- Suffering other clinically relevant disease that, under the opinion of the investigator, might affect the evaluations of efficacy or safety. 15. º.- Participating simultaneously in other clinical study with intervention (or without intervention at the discretion of the investigator and with the consent of the Sponsor) or had participated in other clinical study with intervention within the last 30 days before the inclusion in this study. [‡] 16. º.- If for any reason (planned surgery [including bariatric surgery], trips of long duration, etc.) would not be able to receive the treatment and/or attend the follow-up visits of this study within the next three years and three months. 17. º.- Persons deprived of liberty by judicial or administrative decision, persons under psychiatric treatment and persons placed in a health or social institution for purposes other than those of this clinical study. 18. º.- Adults who are subject to a legal protection measure or who are unable to express their consent. [‡] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications. vi. Exclusion criteria for the second phase of the study: 1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
"Lifestyle modifications" group (Control)
It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months.
Automatic NIV
In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months.
CPAP treatment group
In-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years.
NIV treatment groups
In-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Juan F. Masa Rush University Medical Center

References & Publications (35)

Basoglu OK, Tasbakan MS. Comparison of clinical characteristics in patients with obesity hypoventilation syndrome and obese obstructive sleep apnea syndrome: a case-control study. Clin Respir J. 2014 Apr;8(2):167-74. doi: 10.1111/crj.12054. Epub 2013 Nov — View Citation

Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377. — View Citation

Berger KI, Ayappa I, Chatr-Amontri B, Marfatia A, Sorkin IB, Rapoport DM, Goldring RM. Obesity hypoventilation syndrome as a spectrum of respiratory disturbances during sleep. Chest. 2001 Oct;120(4):1231-8. doi: 10.1378/chest.120.4.1231. — View Citation

Berry RB, Chediak A, Brown LK, Finder J, Gozal D, Iber C, Kushida CA, Morgenthaler T, Rowley JA, Davidson-Ward SL; NPPV Titration Task Force of the American Academy of Sleep Medicine. Best clinical practices for the sleep center adjustment of noninvasive — View Citation

Biring MS, Lewis MI, Liu JT, Mohsenifar Z. Pulmonary physiologic changes of morbid obesity. Am J Med Sci. 1999 Nov;318(5):293-7. doi: 10.1097/00000441-199911000-00002. — View Citation

Borel JC, Burel B, Tamisier R, Dias-Domingos S, Baguet JP, Levy P, Pepin JL. Comorbidities and mortality in hypercapnic obese under domiciliary noninvasive ventilation. PLoS One. 2013;8(1):e52006. doi: 10.1371/journal.pone.0052006. Epub 2013 Jan 16. — View Citation

Budweiser S, Riedl SG, Jorres RA, Heinemann F, Pfeifer M. Mortality and prognostic factors in patients with obesity-hypoventilation syndrome undergoing noninvasive ventilation. J Intern Med. 2007 Apr;261(4):375-83. doi: 10.1111/j.1365-2796.2007.01765.x. — View Citation

Carrillo A, Ferrer M, Gonzalez-Diaz G, Lopez-Martinez A, Llamas N, Alcazar M, Capilla L, Torres A. Noninvasive ventilation in acute hypercapnic respiratory failure caused by obesity hypoventilation syndrome and chronic obstructive pulmonary disease. Am J — View Citation

Castro-Anon O, Perez de Llano LA, De la Fuente Sanchez S, Golpe R, Mendez Marote L, Castro-Castro J, Gonzalez Quintela A. Obesity-hypoventilation syndrome: increased risk of death over sleep apnea syndrome. PLoS One. 2015 Feb 11;10(2):e0117808. doi: 10.13 — View Citation

Chaouat A, Weitzenblum E, Krieger J, Sforza E, Hammad H, Oswald M, Kessler R. Prognostic value of lung function and pulmonary haemodynamics in OSA patients treated with CPAP. Eur Respir J. 1999 May;13(5):1091-6. doi: 10.1034/j.1399-3003.1999.13e25.x. — View Citation

Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B — View Citation

Howard ME, Piper AJ, Stevens B, Holland AE, Yee BJ, Dabscheck E, Mortimer D, Burge AT, Flunt D, Buchan C, Rautela L, Sheers N, Hillman D, Berlowitz DJ. A randomised controlled trial of CPAP versus non-invasive ventilation for initial treatment of obesity — View Citation

Jennum P, Kjellberg J. Health, social and economical consequences of sleep-disordered breathing: a controlled national study. Thorax. 2011 Jul;66(7):560-6. doi: 10.1136/thx.2010.143958. Epub 2011 Jan 2. — View Citation

Kessler R, Chaouat A, Schinkewitch P, Faller M, Casel S, Krieger J, Weitzenblum E. The obesity-hypoventilation syndrome revisited: a prospective study of 34 consecutive cases. Chest. 2001 Aug;120(2):369-76. doi: 10.1378/chest.120.2.369. — View Citation

Lee WY, Mokhlesi B. Diagnosis and management of obesity hypoventilation syndrome in the ICU. Crit Care Clin. 2008 Jul;24(3):533-49, vii. doi: 10.1016/j.ccc.2008.02.003. — View Citation

Leech J, Onal E, Aronson R, Lopata M. Voluntary hyperventilation in obesity hypoventilation. Chest. 1991 Nov;100(5):1334-8. doi: 10.1378/chest.100.5.1334. — View Citation

MacGregor MI, Block AJ, Ball WC Jr. Topics in clinical medicine: serious complications and sudden death in the Pickwickian syndrome. Johns Hopkins Med J. 1970 May;126(5):279-95. No abstract available. — View Citation

Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046- — View Citation

Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. P — View Citation

Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, San — View Citation

Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protecti — View Citation

Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo — View Citation

Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019. — View Citation

McArdle N, Rea C, King S, Maddison K, Ramanan D, Ketheeswaran S, Erikli L, Baker V, Armitstead J, Richards G, Singh B, Hillman D, Eastwood P. Treating Chronic Hypoventilation With Automatic Adjustable Versus Fixed EPAP Intelligent Volume-Assured Positive — View Citation

Miller A, Granada M. In-hospital mortality in the Pickwickian syndrome. Am J Med. 1974 Feb;56(2):144-50. doi: 10.1016/0002-9343(74)90591-9. No abstract available. — View Citation

Mokhlesi B, Masa JF, Brozek JL, Gurubhagavatula I, Murphy PB, Piper AJ, Tulaimat A, Afshar M, Balachandran JS, Dweik RA, Grunstein RR, Hart N, Kaw R, Lorenzi-Filho G, Pamidi S, Patel BK, Patil SP, Pepin JL, Soghier I, Tamae Kakazu M, Teodorescu M. Evaluat — View Citation

Mokhlesi B. Obesity hypoventilation syndrome: a state-of-the-art review. Respir Care. 2010 Oct;55(10):1347-62; discussion 1363-5. — View Citation

Murphy PB, Davidson C, Hind MD, Simonds A, Williams AJ, Hopkinson NS, Moxham J, Polkey M, Hart N. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled tria — View Citation

Olson AL, Zwillich C. The obesity hypoventilation syndrome. Am J Med. 2005 Sep;118(9):948-56. doi: 10.1016/j.amjmed.2005.03.042. — View Citation

Palm A, Midgren B, Janson C, Lindberg E. Gender differences in patients starting long-term home mechanical ventilation due to obesity hypoventilation syndrome. Respir Med. 2016 Jan;110:73-8. doi: 10.1016/j.rmed.2015.11.010. Epub 2015 Nov 26. — View Citation

Priou P, Hamel JF, Person C, Meslier N, Racineux JL, Urban T, Gagnadoux F. Long-term outcome of noninvasive positive pressure ventilation for obesity hypoventilation syndrome. Chest. 2010 Jul;138(1):84-90. doi: 10.1378/chest.09-2472. Epub 2010 Mar 26. — View Citation

Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815. — View Citation

Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104. — View Citation

Weitzenblum E, Kessler R, Chaouat A. [Alveolar hypoventilation in the obese: the obesity-hypoventilation syndrome]. Rev Pneumol Clin. 2002 Apr;58(2):83-90. French. — View Citation

Zwillich CW, Sutton FD, Pierson DJ, Greagh EM, Weil JV. Decreased hypoxic ventilatory drive in the obesity-hypoventilation syndrome. Am J Med. 1975 Sep;59(3):343-8. doi: 10.1016/0002-9343(75)90392-7. — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other A composite outcome in adherent vs. non-adherent to PAP therapy subgroups Efficacy of automatic NIV treatment versus "lifestyle modifications" treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/day) During 3 months for the first phase or RCT
Other A composite outcome in adherent vs. non-adherent to PAP therapy subgroups Efficacy of automatic NIV treatment versus CPAP treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/days) During 3 years for the second phase or RCT
Other Subgroups according to whether hypercapnia was resolved or not Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with PaCO2 higher or lower of 45 mmHg at the end of follow-up During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Other A composite outcome in subgroups with or without supplemental oxygen at baseline Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without supplemental oxygen therapy at baseline During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Other A composite outcome in subgroups of hypercapnia severity at baseline Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower hypercapnia at baseline (above and below of the median PaCO2 measured in mmHg) During 3 months and During 3 years for first and second phases or sequential RCTs respectively
Other A composite outcome in subgroups of the apnea-hypopnea index severity at baseline Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower apnea-hypopnea index at baseline (above and below of the median apnea-hypopnea index at baseline) During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Other A composite outcome in subgroups with or without hypertension diagnosis at baseline Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without hypertension diagnosis at baseline During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Other A composite outcome in subgroups with different home care providers Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with different home care providers (i.e. AirLiquide) During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Other Validity analysis of EQ 5D-5L test To perform a validity analysis of EQ 5D-5L test During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Primary Medium-term composite hospital resource utilization-mortality Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events 3 months
Primary Long-term composite hospital resource utilization-mortality Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events 3 years
Secondary Hospital admissions Separately the components of the primary outcome: hospital admissions measured as the number of events During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary ICU admissions Separately the components of the primary outcome: ICU admissions measured as the number of events During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Emergency department visits Separately the components of the primary outcome: emergency department visits for any cause measured as the number of events During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary All-cause mortality Separately the components of the primary outcome: All-cause mortality number During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Duration of hospital admissions Duration of hospital admissions measured in days of hospital admission During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Secondary Duration of ICU admissions Duration of ICU admissions measured in days of ICU admission During 3 months and during 3 years for the first and second phase or sequential RCTs respectively
Secondary Number of patients who change of the allocated arms Number of patients who change of the allocated arms During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Causes of change of the allocated treatment Causes of change of the allocated arms During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: lower extremity edema Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: unrefreshing sleep Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: morning fatigue Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: nocturia Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: headache Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: tiredness Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: morning confusion Number of patients into four levels of frequency (no, sometimes, usually and always) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: dysnea Number of patients with dysnea according to the Medical Research Council scale classified into five levels of intensity (from 0 to 4) During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Clinical symptoms: sleepiness Level of perceived sleepiness measured by the Epworth Sleepiness Scale During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ-- Scoring of Functional Outcomes of Sleep Questionnaire-- FOSQ--- During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Secondary Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L Scoring of European health-related quality of life questionnaire (EuroQol) EQ-5D-5L During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L Scoring of Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) measured in percentage. During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Arterial blood gases (ABG): PaO2 PaO2 in mmHg During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Arterial blood gases (ABG): PaCO2 PaCO2 in mmHg During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Arterial blood gases (ABG): Bicarbonate bicarbonate measured in mmol/L During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Arterial blood gases (ABG): pH pH During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Weight weight in Kg During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Standardized blood pressure measures Systolic and diastolic blood pressure measured in mmHg During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: systemic hypertension Incidence of hypertension diagnosis or initiation of a new anti-hypertensive treatment During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: arrhythmia Incidence of arrhythmia During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: nonfatal myocardial infarction Incidence of nonfatal myocardial infarction During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: hospitalization for unstable angina Incidence of hospitalization for unstable angina During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: coronary percutaneous interventions Incidence of coronary percutaneous interventions After 3 months and after 3 years for first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack Incidence of nonfatal stroke or transient ischemic attack During 3 months and during 3 years for first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: heart failure episode Incidence of heart failure episode During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of cardiovascular events: cardiovascular death Incidence of cardiovascular death. During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Incidence of adverse event Number of adverse events according to Treatment-Related Adverse Events as assessed by CTCAE v5.0 During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY) Differences in within trial costs will be related with the differences in effectiveness (primary outcome and QALY) between arms using a probabilistic approach to calculate the cost-effectiveness plane. During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Number of oro-tracheal intubation Number of the tracheal intubations During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
Secondary Duration of tracheal intubation Duration of tracheal intubation During 3 months and during 3 years for the first and second phases or sequential RCTs respectively
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06367686 - Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Completed NCT06442163 - Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome N/A
Not yet recruiting NCT05805293 - HVNI Versus NIV In Management Of Acute Hypercapnic Respiratory Failure In OHS N/A
Active, not recruiting NCT05167201 - Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom N/A
Completed NCT04884165 - Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation N/A
Recruiting NCT06090149 - Telemedical Assistance in Automatic Titration of Oxygen for Intensive Care Patients N/A
Active, not recruiting NCT05448443 - Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome Phase 2
Recruiting NCT04025528 - Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention
Recruiting NCT04688125 - Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
Recruiting NCT05398068 - Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome N/A
Completed NCT04615078 - Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation N/A
Completed NCT04835558 - Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
Completed NCT04570540 - Obesity in Sleep Medicine - Focusing on OHS Phenotypes
Not yet recruiting NCT06136533 - The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
Withdrawn NCT01991535 - Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern N/A