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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05051514
Other study ID # BEU_1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 18, 2021
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years old. - Getting a diagnosis of OSAS with polysomnography. - Agree to participate in the study. Exclusion Criteria: - Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.). - Sedative, hypnotic drug intake. Use of medical supplements such as diazepam. - Hypothyroidism, acromegaly. - Diagnosis of a psychiatric illness. - Uncontrolled arrhythmia causing symptoms or hemodynamic impairment. - Pulmonary edema. Pregnancy.

Study Design


Intervention

Diagnostic Test:
Evaluation
To examine the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.

Locations

Country Name City State
Turkey Bitlis State Hospital Bitlis

Sponsors (2)

Lead Sponsor Collaborator
Okan University Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life evaluation The Short-form 36 questionaire is used to measure Quality of life assessment of Patients. The 36-Item Short Form (SF-36) is an often used, well-researched, self-reported measure of health. It comprises 36 questions that cover eight domains of health. These; physical function (10 items), social function (2 items), role difficulty due to physical problems (4 items) and emotional problems (3 items), mental health (5 items), vitality (4 items), bodily pain (2 item), general health (5 items). Day 1.
Primary Postural stability The 30 Seconds Sit to Stand Test is a method used to measure the lower extremity muscle strength and postural stability. Day 1.
Secondary Anxiety and depression The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed to determine the risk levels of patients in terms of anxiety and depression. HADS consists of two subscales, one measuring anxiety, with seven items, and another measuring depression, with seven items, which score separately. Those with a score of 10 and above for the anxiety subscale and those with a score of 7 and above for the depression subscale are defined as high-risk patients. Day 1.
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