Obstruvtive Sleep Apnea Syndrome (OSAS)NCT06383299
The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index
An observational study of Obstruvtive Sleep Apnea Syndrome (OSAS), run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstruvtive Sleep Apnea Syndrome (OSAS)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Aug 2021
- How long will I take part?
- 2 Weeks
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Obstructive sleep apnea syndrome
Who may be able to join
- Age ≥18
- Apnea hypopnea index (AHI) of ≥5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstruvtive Sleep Apnea Syndrome (OSAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | untreated group | |
| 2 | cpap treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calgary Sleep Apnea Quality of Life İndex (C-SAQLI)
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.
Measured: time 0 and two week later
Short Form 36
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.
Measured: time 0 and two week later
Epworth Sleepiness Scale
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.
Measured: time 0 and two week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstruvtive Sleep Apnea Syndrome (OSAS)Studies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Anaforoglu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383299
- Sponsor's protocol ID
- AnkaraYbuMNC
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of Calgary Sleep Apnea Quality of Life Index
- ClinicalTrials.gov ID
- NCT06383299
- Acronym / sponsor ID
- AnkaraYbuMNC
- Conditions
- Obstruvtive Sleep Apnea Syndrome (OSAS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Apr 2024 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –untreated group |
| 2 | – | –cpap treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive sleep apnea syndrome
Key inclusion criteria (2 listed)
- Age ≥18
- Apnea hypopnea index (AHI) of ≥5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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 25 Apr 2024.
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 Obstruvtive Sleep Apnea Syndrome (OSAS), run by Ankara Yildirim Beyazıt 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 2 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 25 Apr 2024. 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?
Calgary Sleep Apnea Quality of Life İndex (C-SAQLI) (time frame: time 0 and two week later). 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?
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 25 Apr 2024.