Sleep VariabilityNCT04263428
The Effects of Sleep Variability in Youth
A study testing Irregular sleep in people with Sleep Variability, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Variability
- What is being tested?
- Irregular sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 1 Jan 2021
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Habitual sleep duration > 7 h/day.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: 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.
- Conditions
- Sleep Variability
- Being tested
- Irregular sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irregular sleepBehavioural
Experimental-induced sleep variability
| Study group | Role | What they receive |
|---|---|---|
| Irregular sleep | Experimental | 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). Receives: Behavioral: Irregular sleep |
| Regular sleep | No intervention | Participants sleep in lab while being monitored with polysomnography for 8 consecutive nights of 7.5 h time in bed (0:00-7:30). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleepiness
As measured by the Stanford Sleepiness Scalen (SSS)
Measured: 7 days (every morning and evening)
Mood
mood state as measured by the Positive and Negative Affect Scale (PANAS).
Measured: 7 days (every morning and evening)
Cognitive functioning - Sustained attention
Sustained attention as measured by psychomotor vigilance task (PVT)
Measured: 7 days (every morning and evening)
Cognitive functioning - processing speed
Processing speed as measured by Digit Symbol Substitution Test (DSST)
Measured: 7 days
Cognitive functioning - inhibition
Inhibition as measured by stop-signal reaction time (SSRT)
Measured: 7 days
Cognitive functioning - working memory
working memory as measured by 2-back task
Measured: 7 days
Secondary outcomes (4)
Sleep quality
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.
Measured: 7 days
Sleep architecture
Sleep stagings (e.g., SWS%, REM duration) and sleep EEG spectrums as analysed from PSG recordings.
Measured: 7 days
Heart rate variability
Resting heart rate and heart rate variability are measured in the morning, evening and during the night.
Measured: 7 days
Cortisol awakening response
Cortisol awakening response is assessed before and after the manipulation.
Measured: baseline, post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep VariabilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Dr. Shirley X. Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263428
- Sponsor's protocol ID
- EA1708030
- Status last verified
- May 2021
- First submitted
- 15 Jun 2019
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sleep Variability on Sleep Quality, Daytime Functioning and Cardiometabolic Regulation in Youth
- ClinicalTrials.gov ID
- NCT04263428
- Acronym / sponsor ID
- EA1708030
- Conditions
- Sleep Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 10 Feb 2020 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irregular sleep | Experimental | Behavioral: Irregular sleepParticipants 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). |
| Regular sleep | No intervention | –Participants sleep in lab while being monitored with polysomnography for 8 consecutive nights of 7.5 h time in bed (0:00-7:30). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Habitual sleep duration > 7 h/day.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Irregular sleepExperimental-induced sleep variability | Behavioural | Irregular sleep |
Primary outcome
Subjective sleepiness
Time frame: 7 days (every morning and evening)
As measured by the Stanford Sleepiness Scalen (SSS)
Mood
Time frame: 7 days (every morning and evening)
mood state as measured by the Positive and Negative Affect Scale (PANAS).
Cognitive functioning - Sustained attention
Time frame: 7 days (every morning and evening)
Sustained attention as measured by psychomotor vigilance task (PVT)
Cognitive functioning - processing speed
Time frame: 7 days
Processing speed as measured by Digit Symbol Substitution Test (DSST)
Cognitive functioning - inhibition
Time frame: 7 days
Inhibition as measured by stop-signal reaction time (SSRT)
Cognitive functioning - working memory
Time frame: 7 days
working memory as measured by 2-back task
4 secondary outcomes
Sleep quality
Time frame: 7 days
Sleep architecture
Time frame: 7 days
Heart rate variability
Time frame: 7 days
Cortisol awakening response
Time frame: baseline, post-intervention
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 11 May 2021.
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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.
Dr. Shirley X. Li principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irregular sleep in people with Sleep Variability, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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 11 May 2021. 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 Hong Kong. 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?
Subjective sleepiness (time frame: 7 days (every morning and evening)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.