Clinical trial NCT03300700: Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea
Official title: Cardiopulmonary Exercise Test in Patient With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted as prospective study including 50 patients either admitted at our chest department or presented at our out patient clinic and diagnosed as Obstructive sleep apnea according to clinical picture and sleep study.

Brief 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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Ventilatory parameters of cardiopulmonary exercise test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Raafat T El-Sokkary, prof
role: STUDY_DIRECTOR
References:
citation: McNamara SG, Grunstein RR, Sullivan CE. Obstructive sleep apnoea. Thorax. 1993 Jul;48(7):754-64. doi: 10.1136/thx.48.7.754. No abstract available.
citation: Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
citation: 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. doi: 10.1378/chest.103.5.1336.
citation: Ozturk 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. doi: 10.1007/s11325-005-0006-1.
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. doi: 10.1016/j.smrv.2005.01.006.