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

NCT06006520 | Completed

• 1 other identifier: Uskudar60
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Osa Syndrome

Keywords

OSAS; quality of life; sleep

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

control group

ACTIVE COMPARATOR

No exercises will be given.

Other: control

oropharyngeal

EXPERIMENTAL

oropharyngeal exercises will be given.

Other: oro-granary exercises.

aerobic

EXPERIMENTAL

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

Other: oro-granary exercises.; Other: aerobic exercises

Interventions

control OTHER

No exercises will be given.

control group

oro-granary exercises. OTHER

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

aerobic; oropharyngeal

aerobic exercises 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.

aerobic

Eligibility Criteria

• Age: 18 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Bolu

Bolu, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33713177 BACKGROUND

• 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.

  PMID: 23873222 BACKGROUND

• 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.

  PMID: 33716919 BACKGROUND

• 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.

  PMID: 29409812 BACKGROUND

• 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.

  PMID: 19234106 BACKGROUND

• 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.

  PMID: 39302514 DERIVED

MeSH Terms

Conditions

Carnevale syndrome

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eda ARSLAN

  Uskudar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: oropharyngeal exercises and aerobic exercises

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 5, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)