Effects of Exercise on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome

Osa Syndrome Clinical Trial

Official title:

Investigation of the Effects of Aerobic and Oropharyngeal Exercises on Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006520
• Other study ID #: Uskudar60
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: February 2024
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 5, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 18-45

• Apnea Hypopnea Index 5 =

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

Related Conditions & MeSH terms

• Osa Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• control
No exercises will be given.
• oro-granary exercises.
soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises
• aerobic exercises
We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; It includes activities such as walking, cycling, jogging, aerobic dancing, swimming.

Locations

Country	Name	City	State
Turkey	Bolu	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale	It is used to measure the general sleepiness of people during the day. In Epworth Sleepiness Scale, 4 ratings are made for a total of 8 questions. The total score was 24, and more than 10 points were considered as daytime sleepiness.	10 weeks
Primary	Pittsburgh Sleep Quality Survey	The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.	10 weeks
Primary	Fatigue Severity Scale	The person indicates how much he or she agrees with each item by choosing numbers from 1 to 7. 1 means completely disagree, 7 means completely agree. The score range of the scale, which consists of 9 questions in total, is 9-63. A score of 36 or higher indicates severe fatigue.	10 weeks
Primary	Berlin Survey	It is a questionnaire consisting of questions about snoring, daytime sleepiness, and high blood pressure, which have been shown to be risk factors for sleep apnea in previous sleep studies. Presence of snoring more than 3-4 times a week, presence of witnessed sleep apnea, daytime sleepiness more than 3-4 times a week and presence of at least two of the conditions were considered risky for sleep apnea syndrome.	10 weeks
Primary	Functional Outcomes of Sleep Scale (FOSQ)	It is a test used to evaluate the physical, social and mental effects of excessive daytime sleepiness on daily life activities. In the Turkish version of the FOSQ, questions about sexual activities are excluded and it consists of 26 questions. Each question is evaluated as no difficulty, mild, moderate, extreme and scored between 0-4 points. Calculation of low scores in total indicates functional disability. Turkish validity and reliability have been demonstrated.	10 weeks