NCT05051514

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

April 18, 2021

Last Update Submit

June 30, 2022

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

  • Postural stability

    The 30 Seconds Sit to Stand Test is a method used to measure the lower extremity muscle strength and postural stability.

    Day 1.

Secondary Outcomes (1)

  • Anxiety and depression

    Day 1.

Other Outcomes (1)

  • Quality of life evaluation

    Day 1.

Study Arms (2)

No-Mild Severity OSAS

Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour.

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.

Diagnostic Test: Evaluation

Interventions

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.

Moderate to Severe OSASNo-Mild Severity OSAS

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic in Bitlis.

You may qualify if:

  • Age \> 18 years old.
  • Getting a diagnosis of OSAS with polysomnography.
  • Agree to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis State Hospital

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Assistant Professor

Study Record Dates

First Submitted

April 18, 2021

First Posted

September 21, 2021

Study Start

April 18, 2021

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)