Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03614572
Other study ID # 15163071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date October 31, 2021

Study information

Verified date November 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic sleep deprivation among adolescents is a prevalent health problem across the world and is associated with a series of short and long term consequences. However, effective interventions targeting on this vulnerable adolescent population is very limited. Majority of the previous sleep education programme are conducted in a school context which personal factors and individualized problems were not addressed. In addition, failure to address "knowledge-action gap" may also explain why individual fail to enact health behaviors even holding positive motivation. In regard to this, investigators proposed an active and person-oriented protocol with the aid of advanced technology in order to improve adolescent sleep health.


Description:

This study will conduct a randomized control trial to evaluate the effectiveness of group-based sleep intervention using motivational interviewing plus text reminders in changing adolescent sleep deprivation problem with both subjective and objective measurements. The intervention will consists of 4 weekly group therapy targeting on adolescent with school day sleep duration less than 7 hours.


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Chinese aged 12-18 years old - Written informed consent of participation into the study is given by adolescents and his/her parents; - Being able to comply with the study protocol; - Having weekday sleep duration less than 7 hours for past 1 month as reported by questionnaire and average of <7hr weekday sleep as reported by sleep diary as an indication of chronic sleep deprivation status. - Possess a mobile phone Exclusion Criteria: - A current or past history of neuropsychiatric disorder(s); - A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality - Having a clinical sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders such as insomnia, delayed sleep phase and narcolepsy. - have enrolled in any intervention programme that may affect their sleep patterns in the past three months or are planning to join intervention programme in the next three month

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group MI
refer to the arm description

Locations

Country Name City State
Hong Kong Department of Psychiatry Sha Tin

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Sleep duration by sleep diary Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (TST) in hours Baseline, 1 week, 3 month and 6 month after treatment
Primary Change of Sleep duration by actigraphy Sleep parameter estimated by actigraphy: total sleep time (TST) in hours Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Sleep knowledge Sleep knowledge is measured by Sleep Knowledge Questionnaire. It consists of 25 items, ranging from -50 to 50 with higher score indicates better sleep knowledge Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Daytime Sleepiness Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness. Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Quality of Life KIDSCREEN-27 health questionnaire for children and young people for the measurement of quality of life by rating 27 items related to general health on a 5 point Likert scale.
There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Sleep Hygiene Adolescent Sleep Hygiene Scale (ASHS): It is a 28-item instrument used to assess how adolescent apply sleep hygiene practice. total score range from 28 to 168 with higher score indicates better sleep practice. The instrument assessed adolescent sleep practice in nine domains: physiological(5 items, score 5-30), cognitive(6 items, score: 6 to 36), emotional(3 items; score: 3-18), sleep environment(4 items; score: 4-24), daytime sleep(1 items; score 1-6), substance(2 items; score: 2 to 12), bedtime routine(1 items; score:1-6), sleep stability(4 items; score: 4 to 16) and bedroom sharing(2 items; score 2-12). Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Anxiety and depressive symptoms Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores. Baseline, 1 week, 3 month and 6 month after treatment
Secondary Change of Academic performance Academic performance is evaluated by the difference in average grade point between baseline, 3 month and 6 month. Baseline, 3 month and 6 month after treatment
Secondary Change of objective cognitive performance (inhibitory ability) Go/No-go Task for assessing inhibitory ability. In Go/No-go Task, a higher error rate indicates lower inhibition control. Baseline, 3 month and 6 month after treatment
Secondary Change of objective cognitive performance (working memory by digit span) Digit Span Task for assessing working memory capacity. In Digit Span Task, a higher number of recalled digits indicates better working memory. Baseline, 3 month and 6 month after treatment
Secondary Change of objective cognitive performance (working memory by N-Back) N-back Task for assessing working memory capacity and manipulation. In N-back Task, a d prime score will be calculated based on the signal detection theory, where a higher score indicates better working memory performance. Baseline, 3 month and 6 month after treatment
Secondary Change of risk-taking & decision making Balloon Analogue Risk Task for assessing risk-taking and decision-making. In Balloon Analogue Risk Task, a score will be calculated by averaging the number of pumps on unexploded blue balloons, where a higher score indicates more risk-taking and impulsive propensities. Baseline, 3 month and 6 month after treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Withdrawn NCT04049682 - Start Times and Restful Sleep
Completed NCT03182413 - Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation Phase 1
Not yet recruiting NCT01930279 - Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood N/A
Completed NCT01989741 - Effect of Sleep Restriction on Decision Making and Inflammation N/A
Completed NCT00228215 - Tips for Infant and Parent Sleep (TIPS) N/A
Completed NCT00123214 - A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation N/A
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT04179838 - Olfactory Contributions to Sleep-dependent Food Craving N/A
Not yet recruiting NCT05513339 - Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
Recruiting NCT05026541 - Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT06017882 - Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload
Completed NCT00179322 - Effects of Sleep Deprivation and Recovery on Cognitive Functions
Recruiting NCT06399939 - The Function of Biphasic Sleep in Infants N/A
Not yet recruiting NCT06027047 - Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)
Completed NCT05162105 - Quick Returns - Sleep, Cognitive Functions and Individual Differences N/A
Completed NCT03981770 - Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery