The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index

April 22, 2024 updated by: Bahar Anaforoglu, Ankara Yildirim Beyazıt University

Turkish Validity and Reliability of Calgary Sleep Apnea Quality of Life Index

The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Yildirim Beyazıt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Obstructive sleep apnea syndrome

Description

Inclusion Criteria:

  • Age ≥18
  • Apnea hypopnea index (AHI) of ≥5

Exclusion Criteria:

  • Presence of sleep disturbances other than OSAS
  • Presence of active alcohol or drug addiction
  • Psychiatric impairment
  • Cognitive impairment
  • Recent acute illness (such as myocardial infarction) that may adversely affect their quality of life
  • Difficulty in communicating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
untreated group
2
cpap treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calgary Sleep Apnea Quality of Life İndex (C-SAQLI)
Time Frame: time 0 and two week later
The C-SAQLI was developed as a sleep apnea specific quality of life instrument It is a 35-item questionnaire that measures the negative impact of sleep apnea on daily functions, social interactions, emotional functions, and symptoms. Items are scored on a 7-point scale with "all of the time" and "not at all" being the most extreme responses. Item and domain scores are averaged to yield a composite total score between 1 and 7. Higher scores represent better quality of life.
time 0 and two week later
Short Form 36
Time Frame: time 0 and two week later
The SF-36 is a multipurpose self-administered health survey consisting of 36 questions divided into 8 individual domains. These 8 sections are as follows; (1) physical functioning , (2) role physical , (3) bodily pain, (4) general health perceptions; (5) vitality , (6) social functioning, (7) role emotional, and (8) general mental health.
time 0 and two week later
Epworth Sleepiness Scale
Time Frame: time 0 and two week later
The ESS is an eight-item questionnaire that measure daytime sleepiness. The questionnaire is in a four-Likert (0-3) response format and the score ranges from 0 to 24. Higher scores indicate more daytime sleepiness.
time 0 and two week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraYbuMNC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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