SleepNCT02551913
A Theory-based Sleep Intervention in Improving Sleep Quality in Adolescents
A study testing Intervention in people with Sleep, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,841 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Apr 2017
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- They are not involved in any sleep education program
- study at secondary schools in Qazvin city
- Ability to understand Persian language
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Theory-based Sleep Hygiene Intervention in Improving Sleep Quality in Adolescents: a Cluster Randomized Controlled Trial
Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher levels of risk-taking behavior, poor school performance, and increased risk of unintentional injuries. As an US study has shown, sleepiness was the major causal factor in many traffic accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving sleep quality in adolescents.
- Conditions
- Sleep
- Being tested
- Control, Intervention
- Keywords
- Psychological Theory, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
the adolescents will not receive any specific intervention
InterventionBehavioural
A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | The adolescents will not receive any specific information Receives: Behavioral: Control |
| Intervention | Experimental | The adolescents will receive relevant information on the importance of adequate sleep, the consequences of sleep deprivation, Provide information about others' approval,Provide normative information about others' behaviour,Goal setting ,action planning, coping planning, Set graded tasks,Prompt self-monitoring of sleep behaviour Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported Sleep hygiene behavior
Sleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep
Measured: changes from baseline , 1 month and 6 Months follow-up
Changes in Sleep duration
Sleep duration will be measured using the Pittsburgh Sleep Quality Index (PSIQ). The PSQI is a self-administered questionnaire to assess subjective sleep quality during the previous month (Buysse et al., 1989). The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3): sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbance; use of sleeping medication; and daytime dysfunction.
Measured: changes from baseline , 1 month and 6 Months follow-up
Secondary outcomes (7)
Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)
psychological predictors of sleep hygiene behavior were assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5.
Measured: changes from baseline , 1 month and 6 Months follow-up
Adolescent Sleep Hygiene Scale
Measured: changes from baseline , 1 month and 6 Months follow-up
General Health Questionnaire
A self-administered questionnaire will be given to each participant, in which the PSQI-I, the Iranian version of the General Health Questionnaire 12 (GHQ12-I)
Measured: changes from baseline , 1 month and 6 Months follow-up
Pediatric Daytime Sleepiness Scale
Measured: changes from baseline , 1 month and 6 Months follow-up
Sleep Disturbances Scale for Children
Measured: changes from baseline , 1 month and 6 Months follow-up
Changes in health-related quality of life
health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ Short Form 15 Generic Core Scales.
Measured: changes from baseline , 1 month and 6 Months follow-up
Sleep knowledge questionnaire
Measured: changes from baseline , 1 month and 6 Months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551913
- Sponsor's protocol ID
- QUMS398
- Status last verified
- Feb 2018
- First submitted
- 11 Sep 2015
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin CY, Strong C, Scott AJ, Brostrom A, Pakpour AH, Webb TL. A cluster randomized controlled trial of a theory-based sleep hygiene intervention for adolescents. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy170.
PubMed 30423178
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Theory-based Sleep Hygiene Intervention in Improving Sleep Quality in Adolescents: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02551913
- Acronym / sponsor ID
- QUMS398
- Conditions
- Sleep
- Keywords
- Psychological Theory, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,841 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher levels of risk-taking behavior, poor school performance, and increased risk of unintentional injuries. As an US study has shown, sleepiness was the major causal factor in many traffic accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving sleep quality in adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: ControlThe adolescents will not receive any specific information |
| Intervention | Experimental | Behavioral: InterventionThe adolescents will receive relevant information on the importance of adequate sleep, the consequences of sleep deprivation, Provide information about others' approval,Provide normative information about others' behaviour,Goal setting ,action planning, coping planning, Set graded tasks,Prompt self-monitoring of sleep behaviour |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- They are not involved in any sleep education program
- study at secondary schools in Qazvin city
- Ability to understand Persian language
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Controlthe adolescents will not receive any specific intervention | Behavioural | control |
| InterventionA theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent | Behavioural | Intervention |
Primary outcome
Changes in self-reported Sleep hygiene behavior
Time frame: changes from baseline , 1 month and 6 Months follow-up
Sleep behavior will be assessed through self-report employing 24-h recall of the previous night's sleep
Changes in Sleep duration
Time frame: changes from baseline , 1 month and 6 Months follow-up
Sleep duration will be measured using the Pittsburgh Sleep Quality Index (PSIQ). The PSQI is a self-administered questionnaire to assess subjective sleep quality during the previous month (Buysse et al., 1989). The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3): sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbance; use of sleeping medication; and daytime dysfunction.
7 secondary outcomes
Changes in psychological predictors of sleep hygiene behavior (attitude, subjective norms intention, perceived behavioral control , Self-monitoring, action planning and coping planning)
Time frame: changes from baseline , 1 month and 6 Months follow-up
Adolescent Sleep Hygiene Scale
Time frame: changes from baseline , 1 month and 6 Months follow-up
General Health Questionnaire
Time frame: changes from baseline , 1 month and 6 Months follow-up
Pediatric Daytime Sleepiness Scale
Time frame: changes from baseline , 1 month and 6 Months follow-up
Sleep Disturbances Scale for Children
Time frame: changes from baseline , 1 month and 6 Months follow-up
Changes in health-related quality of life
Time frame: changes from baseline , 1 month and 6 Months follow-up
Sleep knowledge questionnaire
Time frame: changes from baseline , 1 month and 6 Months follow-up
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 9 Feb 2018.
- Derived from this study: PubMed 30423178Lin CY, Strong C, Scott AJ, Brostrom A, Pakpour AH, Webb TL. A cluster randomized controlled trial of a theory-based sleep hygiene intervention for adolescents. Sleep. 2018 Nov 1;41(11). doi: 10.1093/sleep/zsy170.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Sleep, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 3 inclusion and 1 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 9 Feb 2018. 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 Iran. 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?
Changes in self-reported Sleep hygiene behavior (time frame: changes from baseline , 1 month and 6 Months follow-up). 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?
On the ClinicalTrials.gov record for NCT02551913, which also lists 1 linked publication.
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 9 Feb 2018.