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NCT Number: NCT06006520

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

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).

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Key information

Conditions

Osa Syndrome Carnevale syndrome

Age range

18 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu

Bolu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

No exercises will be given.

oro-granary exercises.

Other

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

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.

Primary outcomes

  1. Epworth Sleepiness Scale

    Time frame: 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.

  2. Pittsburgh Sleep Quality Survey

    Time frame: 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.

  3. Fatigue Severity Scale

    Time frame: 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.

  4. Berlin Survey

    Time frame: 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.

  5. Functional Outcomes of Sleep Scale (FOSQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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