Obstructive Sleep Apnea SyndromeOSASRehabNCT05051514
Physical Status of OSA Patients
An observational study of Obstructive Sleep Apnea Syndrome, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Evaluation
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2021to 30 May 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Primary care clinic in Bitlis.
Who may be able to join
- Age > 18 years old.
- Getting a diagnosis of OSAS with polysomnography.
- Agree to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Evaluation
- 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.
EvaluationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| No-Mild Severity OSAS | Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour. Receives: Diagnostic Test: Evaluation | |
| 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. Receives: Diagnostic Test: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability
The 30 Seconds Sit to Stand Test is a method used to measure the lower extremity muscle strength and postural stability.
Measured: Day 1.
Secondary outcomes (1)
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.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start18 Apr 2021
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University
- Responsible party
- Principal investigator, Tülay Çevik, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051514
- Sponsor's protocol ID
- BEU_1
- Acronym
- OSASRehab
- Status last verified
- Jun 2022
- First submitted
- 18 Apr 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Postural Stability, Quality of Life, Depression in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05051514
- Acronym / sponsor ID
- OSASRehab / BEU_1
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Bitlis Eren University
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 21 Sep 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Mild Severity OSAS | – | Diagnostic Test: EvaluationMild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour. |
| Moderate to Severe OSAS | – | Diagnostic Test: EvaluationModerate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic in Bitlis.
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Getting a diagnosis of OSAS with polysomnography.
- Agree to participate in the study.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| EvaluationTo examine the differences in postural stability, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. | Diagnostic test | Moderate to Severe OSAS, No-Mild Severity OSAS |
Primary outcome
Postural stability
Time frame: Day 1.
The 30 Seconds Sit to Stand Test is a method used to measure the lower extremity muscle strength and postural stability.
1 secondary outcome
Anxiety and depression
Time frame: Day 1.
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 5 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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 Syndrome, run by Okan 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 6 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 5 Jul 2022. 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 (time frame: Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022.