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

Sponsor

Uskudar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006520

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Osa Syndrome	Other: control Other: oro-granary exercises. Other: aerobic exercises	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

oropharyngeal exercises and aerobic exercisesoropharyngeal exercises and aerobic exercises

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group No exercises will be given.	Other: control No exercises will be given.
Experimental: oropharyngeal oropharyngeal exercises will be given.	Other: oro-granary exercises. soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises
Experimental: aerobic 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. soft palate exercises language exercises facial exercises stomatognathic functions swallowing and chewing exercises 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.

Arm

Intervention/Treatment

Active Comparator: control group

No exercises will be given.

Other: control

No exercises will be given.

Experimental: oropharyngeal

oropharyngeal exercises will be given.

Other: oro-granary exercises.

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

Experimental: aerobic

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.

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

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.

Outcome Measures

Primary Outcome Measures

Epworth Sleepiness Scale [10 weeks]
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 [10 weeks]
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 [10 weeks]
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 [10 weeks]
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) [10 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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