Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03300700
• Other study ID #: CETIPWOSA
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: September 28, 2017
• Start date: October 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Asmaa G Nafady, residant
• Phone: 00201015826887
• Email: asmaanafady5922[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obstructive sleep apnea (OSA) can be described as a condition characterized by repetitive obstruction of the upper airway resulting in oxygen desaturation and awakening from sleep, loud snoring, and increased daytime sleepiness . Many studies have shown that a link exists between OSA and cardiovascular disease, chronic heart failure ischemia, hypertension, obesity, and impaired glucose tolerance . A number of factors are likely to play role in development of clinical OSA syndrome (OSAS) ranging from upper airway anatomy to central respiratory control mechanisms. The pathophysiology of OSA is unclear and complex. Several previous studies have explored pulmonary function in the OSAS patients Interestingly, OSAS has been found to be highly correlated with lower airway obstruction, although it is originally defined as an upper airway disease

Description:

American Sleep Apnea Association considers exercise as a non-pharmacological treatment modality of sleep disorders . Theoretical reviews and hypotheses on the effects of exercise in OSA have suggested thermoregulatory, metabolic, and biochemical mechanisms although clinical trials on the topic are inadequate .

Cardiopulmonary exercise testing (CPET) is used as a stress test to evaluate cardiac, pulmonary, and muscle function. It has also been used to differentiate whether the etiology of impairment of the ca. rdiopulmonary exercise test is cardiac, pulmonary or muscle dysfunction In otherwise healthy subjects, exercise limitation is due to heart disease. Patients with OSAS are frequently overweight and may exhibit lung function abnormalities related to their weight. These include a decrease in the functional residual capacity (FRC) due mainly to a decrease in the expiratory reserve volume (ERV) and a decrease in compliance of the respiratory system. These functional abnormalities cause an increase in the energy cost of breathing. In addition, increased body mass is associated with greater metabolic energy requirements during muscular exercise, resulting in further ventilatory stress. There are reports demonstrating that there are discriminating measurements during exercise in obesity, including a high O2 cost to perform external work, and upward displacement of the VO2 -WR relationship OSAS patients have daytime hypersomnolence, decreased daily activity and tissue hypoxemia which may further impair muscle function and decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise was associated with increased severity of sleep-disordered breathing measurements during exercise in obesity, including a high O2 cost to perform external work, and upward displacement of the VO2 -WR relationship. OSAS patients have daytime hypersomnolence, decreased daily activity and tissue hypoxemia which may further impair muscle function and decrease exercise fitness. Recently, Peppard and Young (2004) found that, independent of body habitus, lack of exercise was associated with increased severity of sleep-disordered breathing

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Stable OSA patients

Exclusion Criteria:

• Cardiovascular diseases .

• Orthopedic or neurological conditions affecting the ability of exercise.

• Patients with previous lung resection or malignancies.

• Patients with liver cell failure, renal failure.

• Muscloskeletal disease.

• Other chronic chest disease eg, ILD.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. — View Citation

McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. Review. — View Citation

Oztürk L, Metin G, Cuhadaroglu C, Utkusavas A, Tutluoglu B. FEF(25-75)/FVC measurements and extrathoracic airway obstruction in obstructive sleep apnea patients. Sleep Breath. 2005 Mar;9(1):33-8. — View Citation

Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. Review. — View Citation

Vgontzas AN, Bixler EO, Chrousos GP. Sleep apnea is a manifestation of the metabolic syndrome. Sleep Med Rev. 2005 Jun;9(3):211-24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory parameters of cardiopulmonary exercise test	End tidal Pco2 and Po2 will be measured in patients with obstructive sleep apnea	30 minutes