Obstructive Sleep Apnea-hypopnea SyndromeNCT04451993
Physical Activity Level in Patients With OSAS During Covid-19 Pandemic
An observational study of Obstructive Sleep Apnea-hypopnea Syndrome, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
As long as the people stay at home because of the Covid 19 outbreak, the investigators assume that the sleep quality of OUAS patients, like everyone else, and the sleep quality of COVID-19 outbreak are reduced due to anxiety and anxiety in people. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea Syndrome
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2020to 30 Sep 2020
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy individuals between 18-70 years old, who are diagnosed with OSAS in the sleep lab at the Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital, and whose local language is Turkish will be included in the study.
Who may be able to join
- Having been diagnosed with OSAS and disease severity determined,
- Being between the age of 19-70,
- Body mass index <40 kg / m2
- Volunteering to participate in the research,
- Not having a mental problem that will hinder the cooperation.
Who cannot join
- To have advanced orthopedic, neurological and cardiovascular disease,
- Having a cognitive problem,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Trabzon
About this study
Official title: Are the Sleep Quality and Physical Activity Levels of Osas Patients Differently From Healthy People During the COVID-19 Pandemic:a Prospective, Descriptive Study
As long as the people stay at home because of the Covid 19 outbreak, the investigators assume that the sleep quality of OUAS patients, like everyone else, and the sleep quality of COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume that sleep quality and physical activity level are related to health literacy level and fear of movement (kinesiophobia). In this study; the investigators aimed to determine how patients are affected by this process by evaluating sleep quality, physical activity, fear of movement and health literacy in OSAS patients during our stay in the COVID-19 outbreak.
Read the detailed description
Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory. Sleep quality, physical activity, fear of movement and health literacy will be evaluated in OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will be tried to reach the maximum patient that can be taken between June 2020 and October 2020.
- Keywords
- physical activity, COVID-19, sleep quality
- Medical subject headings
- Motor Activity, COVID-19, Sleep Initiation and Maintenance Disorders
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 |
|---|---|---|
| OSAS PATIENTS | mild, moderate and severe OSAS patients | |
| HEALTHY INDIVIDUALS | healthy individuals without chronic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
International Physical Activity Questionnaire/ In activity-specific scoring, walking under the heading of the fields is calculated by the sum of the moderate intensity activity and intensive activity in itself.
From these calculations, a score is obtained in MET-minutes. There are 3 categories of physical activity level classification. Physical activity levels are classified as physically inactive (inactive), low level of physical activity (minimally active) and sufficient level of physical activity (very active)
Measured: 1 day
Sleep Quality
The Pittsburgh Sleep Quality Index
Measured: 1 day
Secondary outcomes (3)
Daytime Sleepiness
In order to measure the general sleepiness of people during the day, it was evaluated with a standard questionnaire, which is defined as Epworth sleepiness scale (EUS) and consists of 8 questions. The answers for each question are scored between 0 and 3 and the total score is obtained. The score obtained above 10 in EUS has high sensitivity and specificity for daytime sleepiness.
Measured: 1 day
Fear of movement
Tampa Kinesiophobia Scale (TKS)The person gets a total score between 17-68. The high score on the scale indicates that kinesiophobia is also high
Measured: 1 day
Health literacy
Translated into Turkish TURKEY health literacy SCALE-32 (Tsoy-32) will be used. It was used to evaluate the literacy rates of individuals over the age of 15.
0 indicates the lowest health literacy and 50 indicates the highest health literacy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start25 Jun 2020
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-hypopnea 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityAdem Celik, MD, Study chair, Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451993
- Sponsor's protocol ID
- GO 20/540
- Status last verified
- Feb 2021
- First submitted
- 26 Jun 2020
- Last updated
- 5 Feb 2021
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Sleep Quality and Physical Activity Levels of Osas Patients Differently From Healthy People During the COVID-19 Pandemic:a Prospective, Descriptive Study
- ClinicalTrials.gov ID
- NCT04451993
- Acronym / sponsor ID
- GO 20/540
- Keywords
- physical activity, COVID-19, sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Jun 2020 (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.
As long as the people stay at home because of the Covid 19 outbreak, the investigators assume that the sleep quality of OUAS patients, like everyone else, and the sleep quality of COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume that sleep quality and physical activity level are related to health literacy level and fear of movement (kinesiophobia). In this study; the investigators aimed to determine how patients are affected by this process by evaluating sleep quality, physical activity, fear of movement and health literacy in OSAS patients during our stay in the COVID-19 outbreak.
Detailed description
Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory. Sleep quality, physical activity, fear of movement and health literacy will be evaluated in OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will be tried to reach the maximum patient that can be taken between June 2020 and October 2020.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSAS PATIENTS | – | –mild, moderate and severe OSAS patients |
| HEALTHY INDIVIDUALS | – | –healthy individuals without chronic disease |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy individuals between 18-70 years old, who are diagnosed with OSAS in the sleep lab at the Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital, and whose local language is Turkish will be included in the study.
Key inclusion criteria (5 listed)
- Having been diagnosed with OSAS and disease severity determined,
- Being between the age of 19-70,
- Body mass index <40 kg / m2
- Volunteering to participate in the research,
- Not having a mental problem that will hinder the cooperation.
Key exclusion criteria (2 listed)
- To have advanced orthopedic, neurological and cardiovascular disease,
- Having a cognitive problem,
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
Physical Activity
Time frame: 1 day
International Physical Activity Questionnaire/ In activity-specific scoring, walking under the heading of the fields is calculated by the sum of the moderate intensity activity and intensive activity in itself. From these calculations, a score is obtained in MET-minutes. There are 3 categories of physical activity level classification. Physical activity levels are classified as physically inactive (inactive), low level of physical activity (minimally active) and sufficient level of physical activity (very active)
Sleep Quality
Time frame: 1 day
The Pittsburgh Sleep Quality Index
3 secondary outcomes
Daytime Sleepiness
Time frame: 1 day
Fear of movement
Time frame: 1 day
Health literacy
Time frame: 1 day
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 Feb 2021.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Adem Celik, MD study chair
Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital
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-hypopnea Syndrome, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital 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 5 inclusion and 2 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 Feb 2021. 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?
Physical Activity (time frame: 1 day). The study lists 2 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 5 Feb 2021.