Sleep Variability Clinical Trial
Official title:
The Effects of Sleep Variability on Sleep Quality, Daytime Functioning and Cardiometabolic Regulation in Youth
| NCT number | NCT04263428 |
| Other study ID # | EA1708030 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 1, 2019 |
| Est. completion date | January 1, 2021 |
| Verified date | May 2021 |
| Source | The University of Hong Kong |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 25 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Hong Kong |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subjective sleepiness | As measured by the Stanford Sleepiness Scalen (SSS) | 7 days (every morning and evening) | |
| Primary | Mood | mood state as measured by the Positive and Negative Affect Scale (PANAS). | 7 days (every morning and evening) | |
| Primary | Cognitive functioning - Sustained attention | Sustained attention as measured by psychomotor vigilance task (PVT) | 7 days (every morning and evening) | |
| Primary | Cognitive functioning - processing speed | Processing speed as measured by Digit Symbol Substitution Test (DSST) | 7 days | |
| Primary | Cognitive functioning - inhibition | Inhibition as measured by stop-signal reaction time (SSRT) | 7 days | |
| Primary | Cognitive functioning - working memory | working memory as measured by 2-back task | 7 days | |
| Secondary | 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. | 7 days | |
| Secondary | Sleep architecture | Sleep stagings (e.g., SWS%, REM duration) and sleep EEG spectrums as analysed from PSG recordings. | 7 days | |
| Secondary | Heart rate variability | Resting heart rate and heart rate variability are measured in the morning, evening and during the night. | 7 days | |
| Secondary | Cortisol awakening response | Cortisol awakening response is assessed before and after the manipulation. | baseline, post-intervention |