NCT06306495

Brief Summary

Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
473

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

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

March 27, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

February 6, 2024

Last Update Submit

March 5, 2024

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

insomniaphysical activitystress level

Outcome Measures

Primary Outcomes (1)

  • Prevalence of insomnia in university students

    It will be evaluated with the Pittsburgh Sleep Quality Index. Pittsburgh Sleep Quality Index (PSQI) is a scale that assesses sleep quality and disturbance over the past month. It consists of 24 questions, 19 of which are self-report and 5 of which are answered by a spouse or roommate. The self-report section consisting of 19 questions was used in this study. The 18 scored questions of the scale consist of 7 components (Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleep Medication Use and Daytime Dysfunction). Each component is evaluated on a 0-3 point scale and the total score of the 7 components gives the total score of the scale. The total score varies between 0 and 21. A total score greater than 5 means "poor sleep quality"

    17 months

Secondary Outcomes (3)

  • The effect of insomnia on physical activity level

    17 months

  • The effect of insomnia on stress levels in university students

    17 months

  • Effects of sleep hygiene on insomnia in university students

    17 months

Study Arms (1)

University students

Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale and Pittsburgh Sleep Quality Index administered to all participants.

Other: International Physical Activity Survey

Interventions

International Physical Activity SurveyOTHER

Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale and Pittsburgh Sleep Quality Index administered to all participants.

Also known as: Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, Pittsburgh Sleep Quality Index
University students

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population of the study is university education in the Marmara Region. consists of continuing students. The study sample consists of associate and undergraduate students studying in the field of Health Sciences, between the ages of 18-25, who continue their university education in Istanbul and Yalova.

You may qualify if:

  • Between the ages of 18-25,
  • Associate and undergraduate students studying in the field of health sciences
  • Agreeing to participate in the study,
  • Native speaker of Turkish,
  • Male and female individuals

You may not qualify if:

  • Refusing to participate in the study,
  • Having a diagnosed psychiatric illness,
  • Using any medical medication that affects sleep
  • Having a health condition that prevents physical activity,
  • Be missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Sutton EL. Insomnia. Ann Intern Med. 2021 Mar;174(3):ITC33-ITC48. doi: 10.7326/AITC202103160. Epub 2021 Mar 9.

    PMID: 33683929RESULT

  • Amaral AP, Soares MJ, Pinto AM, Pereira AT, Madeira N, Bos SC, Marques M, Roque C, Macedo A. Sleep difficulties in college students: The role of stress, affect and cognitive processes. Psychiatry Res. 2018 Feb;260:331-337. doi: 10.1016/j.psychres.2017.11.072. Epub 2017 Dec 2.

    PMID: 29227897RESULT

  • Williams AB, Dzierzewski JM, Griffin SC, Lind MJ, Dick D, Rybarczyk BD. Insomnia Disorder and Behaviorally Induced Insufficient Sleep Syndrome: Prevalence and Relationship to Depression in College Students. Behav Sleep Med. 2020 Mar-Apr;18(2):275-286. doi: 10.1080/15402002.2019.1578772. Epub 2019 Feb 21.

    PMID: 30789063RESULT

  • Hartescu I, Morgan K. Regular physical activity and insomnia: An international perspective. J Sleep Res. 2019 Apr;28(2):e12745. doi: 10.1111/jsr.12745. Epub 2018 Aug 16.

    PMID: 30117220RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Study Officials

  • Özge Ökcü, phdc

    Halic University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 12, 2024

Study Start

March 27, 2022

Primary Completion

August 12, 2023

Study Completion

January 29, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)