Clinical trial NCT06006520: Effects of Exercise on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome
Official title: Investigation of the Effects of Aerobic and Oropharyngeal Exercises on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osa Syndrome
Keywords: OSAS
quality of life
sleep
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: oropharyngeal exercises and aerobic exercises
Primary purpose: TREATMENT

Brief summary: the investigators aim in this study is to investigate the effects of aerobic and oropharyngeal exercises on sleep quality in patients with Obstructive Sleep Apnea Syndrome (OSAS).

Detailed description: The study will be conducted in a randomized controlled manner. Participants will be divided into groups of 3 equal numbers using the simple randomization method. The control group will not be given exercise. The first intervention group will be given 10-15 minutes of oropharyngeal exercises. In addition to oropharyngeal exercises, the second intervention group will be given 50 minutes of moderate-intensity aerobic exercise at least 3 days a week. Both intervention groups will apply the given exercise program for 8 weeks. All participants will be evaluated 3 times in total, at the beginning of the treatment, at the 4th week and at the 8th week. Epworth Sleepiness Scale, Pittsburgh Sleep Quality Questionnaire, Fatigue Severity Scale, Berlin Questionnaire, 6-minute walk test, Modified Medical Research Council (MMRC) Dyspnea Scale, Functional Results of Sleep Scale (FOSQ) tests will be applied to the participants. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* People who want to participate in the study voluntarily
* People who do not regularly engage in physical activity
* Persons diagnosed with OSAS in the neurology outpatient clinic
* People between the ages of 18-57
* Apnea Hypopnea Index 15-30

Exclusion Criteria:

* Chronic obstructive pulmonary disease, presence of lung disease that may cause respiratory failure
* -Severe cardiac disease, congestive heart failure, detection of ejection fraction in echocardiography, uncontrollable cardiac ischemia
* History of previous cerebrovascular disease
* Neuromuscular disease
* Presence of periodic leg movements
* Serious medical illness or planned surgical intervention
* Psychiatric illness, substance abuse

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: 10 weeks
measure: Pittsburgh Sleep Quality Survey
timeFrame: 10 weeks
measure: Fatigue Severity Scale
timeFrame: 10 weeks
measure: Berlin Survey
timeFrame: 10 weeks
measure: Functional Outcomes of Sleep Scale (FOSQ)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu
Study officials:
affiliation: Uskudar University
name: Eda ARSLAN
role: STUDY_CHAIR
References:
citation: Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.
citation: Chwiesko-Minarowska S, Minarowski L, Kuryliszyn-Moskal A, Chwiesko J, Chyczewska E. Rehabilitation of patients with obstructive sleep apnea syndrome. Int J Rehabil Res. 2013 Dec;36(4):291-7. doi: 10.1097/MRR.0b013e3283643d5f.
citation: Mohammadi H, Aarabi A, Rezaei M, Khazaie H, Brand S. Sleep Spindle Characteristics in Obstructive Sleep Apnea Syndrome (OSAS). Front Neurol. 2021 Feb 25;12:598632. doi: 10.3389/fneur.2021.598632. eCollection 2021.
citation: Xanthopoulos MS, Berkowitz RI, Tapia IE. Effects of obesity therapies on sleep disorders. Metabolism. 2018 Jul;84:109-117. doi: 10.1016/j.metabol.2018.01.022. Epub 2018 Feb 1.
citation: Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.