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

Primary Purpose

Osa Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
control
oro-granary exercises.
aerobic exercises
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osa Syndrome focused on measuring OSAS, quality of life, sleep

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BoluRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

control group

oropharyngeal

aerobic

Arm Description

No exercises will be given.

oropharyngeal exercises will be given.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06006520
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osa Syndrome
Keywords
OSAS, quality of life, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
oropharyngeal exercises and aerobic exercises
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
No exercises will be given.
Arm Title
oropharyngeal
Arm Type
Experimental
Arm Description
oropharyngeal exercises will be given.
Arm Title
aerobic
Arm Type
Experimental
Arm Description
In addition to oropharyngeal exercises, 50 minutes of moderate-intensity aerobic exercise will be given at least 3 days a week.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No exercises will be given.
Intervention Type
Other
Intervention Name(s)
oro-granary exercises.
Intervention Description
soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises
Intervention Type
Other
Intervention Name(s)
aerobic exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
10 weeks
Title
Pittsburgh Sleep Quality Survey
Description
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.
Time Frame
10 weeks
Title
Fatigue Severity Scale
Description
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.
Time Frame
10 weeks
Title
Berlin Survey
Description
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.
Time Frame
10 weeks
Title
Functional Outcomes of Sleep Scale (FOSQ)
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 18-45 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda ARSLAN
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Bolu
City
Bolu
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda ARSLAN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33713177
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.
Results Reference
background
PubMed Identifier
23873222
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.
Results Reference
background
PubMed Identifier
33716919
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.
Results Reference
background
PubMed Identifier
29409812
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.
Results Reference
background
PubMed Identifier
19234106
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.
Results Reference
background

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

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