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OpenTrials
Completed

NCT Number: NCT03589417

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, Eyup, 34060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Assessments with Biodex Balance System®

Other

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Jun 18, 2019

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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