Physical Status of OSA Patients (OSASRehab)

Examination of Postural Stability, Quality of Life, Depression in Patients With Obstructive Sleep Apnea Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Diagnostic test: Evaluation

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Turkey
  • Bitlis, Turkey, 13000
    • Bitlis State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic in Bitlis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No-Mild Severity OSAS; Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour.	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.
Moderate to Severe OSAS; Moderate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour.Severe sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Okan University
• Collaborators: Bitlis Eren University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
• Other Study ID Numbers: BEU_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No