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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589417
• Other study ID #: bvumzeren02
• Status: Completed
• Start date: September 24, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: June 2019
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Assessments with Biodex Balance System®
Postural Stability, limits of stability and fall risk tests will be applied with the Biodex Balance System®

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation	Istanbul	Eyup

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Stability Test score	'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
Primary	Limits of Stability Test score	'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
Primary	Fall risk Test score	'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