- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263428
The Effects of Sleep Variability in Youth
May 9, 2021 updated by: Dr. Shirley Xin Li, The University of Hong Kong
The Effects of Sleep Variability on Sleep Quality, Daytime Functioning and Cardiometabolic Regulation in Youth
Daily sleep variability is prevalent in the young populations, yet its effects remain less clear.
The experimental study aims to examine the impacts of intraindividual daily sleep variability on sleep characteristics, cardiometabolic regulations and daytime functioning in college students.
Study Overview
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Habitual sleep duration > 7 h/day.
Exclusion Criteria:
- Extreme morning- nor extreme evening-chronotype
- With sleep problems
- With mood and anxiety problems
- With excessive daytime sleepiness
- Have history of any chronic medical condition and on regular medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Irregular sleep
Participants sleep in lab while being monitored with polysomnography for 8 consecutive nights, including an adaptation night and a baseline night of 7.5 h time in bed (0:00-7:30).
Afterwards, they are instructed to sleep in bed on a schedule alternated between 6 h, i.e. 1:30-7:30, and 9 h, i.e. 22:30-7:30).
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Experimental-induced sleep variability
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No Intervention: Regular sleep
Participants sleep in lab while being monitored with polysomnography for 8 consecutive nights of 7.5 h time in bed (0:00-7:30).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective sleepiness
Time Frame: 7 days (every morning and evening)
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As measured by the Stanford Sleepiness Scalen (SSS)
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7 days (every morning and evening)
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Mood
Time Frame: 7 days (every morning and evening)
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mood state as measured by the Positive and Negative Affect Scale (PANAS).
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7 days (every morning and evening)
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Cognitive functioning - Sustained attention
Time Frame: 7 days (every morning and evening)
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Sustained attention as measured by psychomotor vigilance task (PVT)
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7 days (every morning and evening)
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Cognitive functioning - processing speed
Time Frame: 7 days
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Processing speed as measured by Digit Symbol Substitution Test (DSST)
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7 days
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Cognitive functioning - inhibition
Time Frame: 7 days
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Inhibition as measured by stop-signal reaction time (SSRT)
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7 days
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Cognitive functioning - working memory
Time Frame: 7 days
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working memory as measured by 2-back task
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep quality
Time Frame: 7 days
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Actual sleep time, sleep onset latency, wake after sleep onset and night time arousals as measured by actigraphy and PSG.
Sleep satisfactory and dreams as measured by sleep diary.
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7 days
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Sleep architecture
Time Frame: 7 days
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Sleep stagings (e.g., SWS%, REM duration) and sleep EEG spectrums as analysed from PSG recordings.
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7 days
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Heart rate variability
Time Frame: 7 days
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Resting heart rate and heart rate variability are measured in the morning, evening and during the night.
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7 days
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Cortisol awakening response
Time Frame: baseline, post-intervention
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Cortisol awakening response is assessed before and after the manipulation.
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baseline, post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Shirley X. Li, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
June 15, 2019
First Submitted That Met QC Criteria
February 7, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 9, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- EA1708030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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