Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea

June 17, 2019 updated by: Melih Zeren, Bezmialem Vakif University
Obstructive sleep apnea (OSA) is a clinical condition characterized by the repetitive obstruction of the upper airway during sleep, resulting in nocturnal hypoxaemia and fragmented sleep. Fragmented sleep leads to daytime sleepiness that causes alterations in reaction times and reflexes . Postural stability is an important function of the human body. It is shown that the sleep deprivation disturbs daytime postural stability and balance. Aim of this study is to examine the influence of OSA severity and daytime sleepiness on postural stability, balance and fall risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eyup
      • Istanbul, Eyup, Turkey, 34060
        • Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects aged between 30-65 years who are recently diagnosed with mild, moderate or severe OSA (AHI≥5) and not receiving any treatment yet will be included in the study.

Description

Inclusion Criteria:

  • Subjects with recent diagnosis of OSA (AHI≥5)
  • BMI of ≤35 kg/m2
  • Being sedentary

Exclusion Criteria:

  • Having OSA treatments (CPAP, oral devices, nasal surgery, tennis ball/positional therapy, diuretic),
  • Having a disease that can affect balance (vestibular, neurological, orthopedic ...) performing regular exercise
  • Morphological defect (facial malformation, etc.) which may cause sleep disorders
  • Uncontrolled hypertension or arrhythmia
  • History of smoking or alcoholism
  • Orthopedic, neurological or musculoskeletal problems which impede exercising
  • Pregnancy
  • Uncompensated clinical conditions such as chronic obstructive pulmonary disease, interstitial lung disease, heart failure, or rheumatic and psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Stability Test score
Time Frame: Baseline
'Postural Stability Test' will be applied with Biodex Balance System®. Subjects will stand still on the platform and the displacement of the centre of gravity will be quantified for anterior-posterior (AP) and medial-lateral (ML) axes. Test provides three types of scores: overall stability index, anterior-posterior stability index and medial-lateral stability index. Higher scores indicate worse postural stability.
Baseline
Limits of Stability Test score
Time Frame: Baseline
'Limits of Stability Test' will be applied with Biodex Balance System®. Subjects will stand on the platform and lean in eight directions to control the cursor displayed on the screen and try to move the cursor inside the target circles. Test provides scores for all eight directions as well as an overall score. Higher scores indicate better performance (0= worst performance; 100= perfect performance)
Baseline
Fall risk Test score
Time Frame: Baseline
'Fall Risk Test' will be applied with Biodex Balance System®. Subjects will stand still on the platform which will gradually become more unstable for 20 seconds. Total displacement of the centre of gravity will be quantified. Test provides one score: Overall stability index. Higher score indicates higher risk of fall.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2018

Primary Completion (Actual)

April 8, 2019

Study Completion (Actual)

April 8, 2019

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bvumzeren02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Assessments with Biodex Balance System®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe