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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04451993
Other study ID # GO 20/540
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2020
Est. completion date September 30, 2020

Study information

Verified date February 2021
Source Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 30, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: 1. Having been diagnosed with OSAS and disease severity determined, 2. Being between the age of 19-70, 3. Body mass index <40 kg / m2 4. Volunteering to participate in the research, 5. Not having a mental problem that will hinder the cooperation. Exclusion Criteria: 1. To have advanced orthopedic, neurological and cardiovascular disease, 2. Having a cognitive problem,

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Circadian rhythm evaluation In the human circadian rhythm, the Morning Morning-Evening Survey (SAA) form was used, which determined morning and evening types. 1 day
Primary 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)
1 day
Primary Sleep Quality The Pittsburgh Sleep Quality Index 1 day
Secondary 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. 1 day
Secondary 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 1 day
Secondary 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.
1 day
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