Obstructive Sleep ApneaNCT03589417
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 . Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Assessments with Biodex Balance System®
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2018to 8 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects with recent diagnosis of OSA (AHI≥5)
- BMI of ≤35 kg/m2
- Being sedentary
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
Istanbul, Eyup, 34060
About this study
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Assessments with Biodex Balance System®
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments with Biodex Balance System®Other
Postural Stability, limits of stability and fall risk tests will be applied with the Biodex Balance System®
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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)
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start24 Sep 2018
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melih Zeren, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589417
- Sponsor's protocol ID
- bvumzeren02
- Status last verified
- Jun 2019
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yilmaz Gokmen G, Gurses HN, Zeren M, Ozyilmaz S, Kansu A, Akkoyunlu ME. Postural stability and fall risk in patients with obstructive sleep apnea: a cross-sectional study. Sleep Breath. 2021 Dec;25(4):1961-1967. doi: 10.1007/s11325-021-02322-2. Epub 2021 Feb 20.
PubMed 33608798
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03589417
- Acronym / sponsor ID
- bvumzeren02
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Subjects with recent diagnosis of OSA (AHI≥5)
- BMI of ≤35 kg/m2
- Being sedentary
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessments with Biodex Balance System®Postural Stability, limits of stability and fall risk tests will be applied with the Biodex Balance System® | Other | – |
Primary outcome
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.
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 33608798Yilmaz Gokmen G, Gurses HN, Zeren M, Ozyilmaz S, Kansu A, Akkoyunlu ME. Postural stability and fall risk in patients with obstructive sleep apnea: a cross-sectional study. Sleep Breath. 2021 Dec;25(4):1961-1967. doi: 10.1007/s11325-021-02322-2. Epub 2021 Feb 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability Test score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.