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

NCT ID: NCT06006520

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-05

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.

Conditions

Osa Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

No exercises will be given.

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

No exercises will be given.

oropharyngeal

oropharyngeal exercises will be given.

Group Type: EXPERIMENTAL

oro-granary exercises.

Intervention Type: OTHER

soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises

aerobic

In addition to oropharyngeal exercises, 50 minutes of moderate-intensity aerobic exercise will be given at least 3 days a week.

Group Type: EXPERIMENTAL

oro-granary exercises.

Intervention Type: OTHER

soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises

aerobic exercises

Intervention Type: OTHER

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.

Interventions

control

No exercises will be given.

Intervention Type: OTHER

oro-granary exercises.

soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 57 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eda ARSLAN

Role: STUDY_CHAIR

Uskudar University

Locations

Bolu

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 33713177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23873222 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33716919 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29409812 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19234106 (View on PubMed)

Arslan E, Sevgin O. The effects of Aerobic and oropharyngeal exercises on sleep quality of patients with obstructive sleep Apnoea syndrome: a randomized controlled study. Sleep Breath. 2024 Dec;28(6):2729-2736. doi: 10.1007/s11325-024-03157-3. Epub 2024 Sep 20.

Reference Type: DERIVED

PMID: 39302514 (View on PubMed)

Other Identifiers

Uskudar60

Identifier Type: -

Identifier Source: org_study_id