NCT04451993

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

June 26, 2020

Last Update Submit

February 3, 2021

Conditions

Keywords

physical activityCOVID-19sleep quality

Outcome Measures

Primary Outcomes (2)

  • 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

  • Sleep Quality

    The Pittsburgh Sleep Quality Index

    1 day

Secondary Outcomes (3)

  • Daytime Sleepiness

    1 day

  • Fear of movement

    1 day

  • Health literacy

    1 day

Other Outcomes (1)

  • Circadian rhythm evaluation

    1 day

Study Arms (2)

OSAS PATIENTS

mild, moderate and severe OSAS patients

HEALTHY INDIVIDUALS

healthy individuals without chronic disease

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • To have advanced orthopedic, neurological and cardiovascular disease,
  • Having a cognitive problem,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityCOVID-19Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Adem Celik, MD

    Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

June 26, 2020

First Posted

June 30, 2020

Study Start

June 25, 2020

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations