Obstructive Sleep Apnea-hypopnea Syndrome Clinical Trial
— MTASSAOSOfficial title:
Effects of Myofunctional Therapy With an M-health Application Airway Gym in Severe Apnea/Hypopnea Sleep Obstructive Syndrome: A Randomized Multicentre Control Trial
Verified date | June 2020 |
Source | Quironsalud |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
• Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to stop and start repeatedly during sleep. There are several types of sleep apnea, the most common of which is obstructive sleep apnea. This type of apnea occurs when an individual's throat muscles intermittently relax and block the airway during sleep. The classic treatment for this disease is based on weight loss, and exercise, and the use of a continuous positive airway pressure (CPAP) machine. Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing. MT is based on daily exercises of the throat muscles in an attempt to strengthen them and facilitate opening of the airway. Who can participate? Patients diagnosed with severe sleep apnea and aged between 18-75 years. What does the study involve? Participants will be randomly allocated to either use of the "AirwayGym" smartphone app or no treatment for 3 months. The AirwayGym app provides instructions on how to perform exercises to strengthen the throat muscles and reminds participants to perform the exercises for 20 min per day. Participants will be assessed monthly at the clinic. What are the possible benefits and risks of participating? Benefits: Curing sleep apnea syndrome. There are no significant risks for participants. Where is the study run from? Hospital Quirónsalud Marbella (Spain) When is the study starting and how long is it expected to run for? October 2018 to January 2021 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr. Carlos O'Connor Reina, coconnor@us.es
Status | Completed |
Enrollment | 40 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age between 18-75 years - Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology - Consent signed Exclusion Criteria: - BMI > 40 kg/m² - Inability to fill up questionnaires - Severe drug or alcohol abuse - Hypnotic medication - Not controlled coronary disease - Decompensated Heart failure - Stroke - Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…) - Neuromuscular disease (like Duchenne) - Craniofacial deformities. - Active oncologic process. - Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, Mandibular Advancement Device (MAD) or CPAP). Once the patient accepted and signed consent and met inclusion criteria, they will be attended by Ent specialist to rule out: - Severe upper airway obstruction (Complete nose obstruction, Tonsils grade IV/IV ) - Presence of tongue tie (Marchesani protocol) with limitation of tongue movements - Antecedents or presence of temporomandibular joint disorders |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Quironsalud Campo de Gibraltar | Los Barrios | Cadiz |
Spain | Hospital Quironsalud Marbella | Marbella | Malaga |
Lead Sponsor | Collaborator |
---|---|
Quironsalud |
Spain,
Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652. Review. — View Citation
Camacho M, Robertson M, Abdullatif J, Certal V, Kram YA, Ruoff CM, Brietzke SE, Capasso R. Smartphone apps for snoring. J Laryngol Otol. 2015 Oct;129(10):974-9. doi: 10.1017/S0022215115001978. Epub 2015 Sep 3. — View Citation
Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28. — View Citation
Iftikhar IH, Roland J. Obesity Hypoventilation Syndrome. Clin Chest Med. 2018 Jun;39(2):427-436. doi: 10.1016/j.ccm.2018.01.006. Review. — View Citation
Isetta V, Torres M, González K, Ruiz C, Dalmases M, Embid C, Navajas D, Farré R, Montserrat JM. A New mHealth application to support treatment of sleep apnoea patients. J Telemed Telecare. 2017 Jan;23(1):14-18. doi: 10.1177/1357633X15621848. Epub 2016 Jul 8. — View Citation
Korhan I, Gode S, Midilli R, Basoglu OK. The influence of the lateral pharyngeal wall anatomy on snoring and sleep apnoea. J Pak Med Assoc. 2015 Feb;65(2):125-30. — View Citation
Mendes FA, Marone SA, Duarte BB, Arenas AC. Epidemiologic profile of patients with snoring and obstructive sleep apnea in a university hospital. Int Arch Otorhinolaryngol. 2014 Apr;18(2):142-5. doi: 10.1055/s-0033-1359309. Epub 2014 Feb 28. — View Citation
O'Connor Reina C, Plaza Mayor G, Ignacio-Garcia JM, Baptista Jardin P, Garcia-Iriarte MT, Casado-Morente JC. Floppy Closing Door Epiglottis Treated Successfully with an Mhealth Application Based on Myofunctional Therapy: A Case Report. Case Rep Otolaryngo — View Citation
O'Connor-Reina C, Ignacio Garcia JM, Rodriguez Ruiz E, Morillo Dominguez MDC, Ignacio Barrios V, Baptista Jardin P, Casado Morente JC, Garcia Iriarte MT, Plaza G. Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Random — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea Hypopnea Index (AHI) | Measurement of number of apneas or hypopneas recorded during the study per hour of sleep | Baseline and three months | |
Primary | Evaluation of O2 Desaturation Index (ODI) | The ODI is the number of times per hour of sleep that the blood oxygen level drops by a certain degree from baseline. Any respiratory event during sleep with a 3% drop in blood oxygen levels is counted towards the total. For example, a change from 95% to 92% would be an event that is counted toward the index's total. | Baseline and three months | |
Secondary | Evaluation of Iowa Oral Performance Instrument (IOPI) Score | The IOPI objectively measures maximum tongue strength in kilopascals and represents the tone of the genioglossus muscles. | Baseline and three months | |
Secondary | Iowa Oral Performance Instrument Lip Strength | The IOPI objectively measures maximum lip strength in kilopascals and represents the tone of the buccinator muscles. | Baseline and three months | |
Secondary | Neck Circumference (cm) | Gives an idea if there is an anatomical change or reduction in fat in the upper airway muscles after intervention . | Baseline and three months. | |
Secondary | Waist Circumference (cm) | Gives an idea if there is an anatomical change or reduction of fat in the thorax muscles after intervention. | Baseline and three months | |
Secondary | Body Mass Index BMI | is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass in kilograms divided by the square of the body height in meters, and is expressed in units kg/m^2 . | Baseline and three months | |
Secondary | Epworth Sleepiness Scale | A scale (0-24), obtained by self-administered questionnaire, that rates an individual's probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that people experience in their daily lives. | Baseline and three months | |
Secondary | Pittsburgh Sleep Quality Index | A scale (0- 21) obtained by a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire consists of a combination of Likerttype and open-ended questions (later converted to scaled scores using provided guidelines).
Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances.A global score of 5 or more indicates poor sleep quality and that the higher the score, the worse the quality of sleep. The questionnaire consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 min to complete. |
Baseline and three months |
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