Sleep Initiation and Maintenance DisordersPANCT06306495
Insomnia, Physical Activity Level and Stress Level
An observational study of Sleep Initiation and Maintenance Disorders, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- International Physical Activity Survey
- How many people
- 473 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2022to 29 Jan 2024
- How long will I take part?
- 1 Year
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of Insomnia, Physical Activity Level and Stress Level in University Students
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.
- Being tested
- International Physical Activity Survey
- Keywords
- insomnia, physical activity, stress level
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Physical Activity SurveyOther
Also called Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, Pittsburgh Sleep Quality Index
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: International Physical Activity Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 17 months
Secondary outcomes (3)
The effect of insomnia on physical activity level
It will be evaluated with the International Physical Activity Questionnaire Short Form (IPAQ-SF).IPAQ-SF was used to determine physical activity levels. This is a seven-question self-report questionnaire that assesses physical activity over the past 7 days. According to IPAQ-SF records, there are four levels of intensity: sitting, walking, moderate intensity (e.g. leisure cycling) and vigorous intensity (e.g. jogging or aerobics)
Measured: 17 months
The effect of insomnia on stress levels in university students
It will be evaluated with the Distress Tolerance Scale (DTS).DTS; This scale aims to determine the stress endurance of the patient based on individual variations. DTS is a 15-item scale developed to measure individual differences in the capacity to withstand distress. The scale consists of 3 sub-factors (self-efficacy, tolerance, regulation). A high score on the scale indicates indicates a high level of resilience
Measured: 17 months
Effects of sleep hygiene on insomnia in university students
Evaluated by Sleep Hygiene Index (SHI).The SHI form consists of 13 questions and evaluates the sleep behaviors that constitute the sleep hygiene of the participants. Scores ranged from 13 to 65, with higher scores indicating poorer sleep hygiene in the participants. It has been reported that participants with high scores on the form have worse sleep hygiene
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Mar 2022
- Primary completion12 Aug 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 473 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Saka, Halic University
- Investigators
- Özge Ökcü, phdc, Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306495
- Sponsor's protocol ID
- 26.01.2022/17
- Acronym
- PA
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutton EL. Insomnia. Ann Intern Med. 2021 Mar;174(3):ITC33-ITC48. doi: 10.7326/AITC202103160. Epub 2021 Mar 9.
PubMed 33683929Amaral 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.
PubMed 29227897Williams 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.
PubMed 30789063Hartescu 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.
PubMed 30117220
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Insomnia, Physical Activity Level and Stress Level in University Students
- ClinicalTrials.gov ID
- NCT06306495
- Acronym / sponsor ID
- PA / 26.01.2022/17
- Keywords
- insomnia, physical activity, stress level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 12 Aug 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 12 Mar 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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University students | – | Other: International Physical Activity SurveyStudy 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International Physical Activity SurveyAlso: Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, Pittsburgh Sleep Quality IndexStudy 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 | University students |
Primary outcome
Prevalence of insomnia in university students
Time frame: 17 months
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"
3 secondary outcomes
The effect of insomnia on physical activity level
Time frame: 17 months
The effect of insomnia on stress levels in university students
Time frame: 17 months
Effects of sleep hygiene on insomnia in university students
Time frame: 17 months
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 12 Mar 2024.
- Results publication: PubMed 33683929Sutton EL. Insomnia. Ann Intern Med. 2021 Mar;174(3):ITC33-ITC48. doi: 10.7326/AITC202103160. Epub 2021 Mar 9.
- Results publication: PubMed 29227897Amaral 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.
- Results publication: PubMed 30789063Williams 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.
- Results publication: PubMed 30117220Hartescu 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.
- Individual participant dataSharing planned: No
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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.
Özge Ökcü, phdc study director
Halic University
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 Sleep Initiation and Maintenance Disorders, run by Halic 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 5 inclusion and 5 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 12 Mar 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?
Prevalence of insomnia in university students (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306495, which also lists 4 linked publications.
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 12 Mar 2024.