Changes in Sleep Duration and Blood Pressure Across School Holiday in Teenagers

NCT03895710 | Completed

• 1 other identifier: CREC2015.701
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Our research question is: Are changes in sleep duration that occur naturally over school holidays associated with changes in blood pressure (BP) in sleep-deprived adolescents? In this study, the investigators will take advantage of changes in sleep duration that occur during school holidays in adolescents who are sleep deprived (\>6 months' history of sleeping \<8 hours per night during school term). The investigators will monitor the changes in ambulatory BP and sleep duration over a period of 3 weeks which consist of a week at school, followed by a week of holiday when natural sleep extension takes place, and then another week of school after the holiday. Sleep-wake cycle will be recorded throughout the whole study period with actigraphy and sleep diary. Twenty-four hour ambulatory BP monitoring will be performed on the same weekday during each study week, when salivary cortisol will also be collected. The primary outcome measure is the difference in ambulatory BP parameters between school term and holiday. A control group without sleep deprivation (history of sleeping \>8 hours per night) will also be studied concurrently It is hypothesized that changes in sleep duration are negatively associated with changes in BP. If this study confirms our hypothesis, sleep extension can be used as a relatively inexpensive and simple behavioural intervention in the management and prevention of blood pressure abnormalities. More importantly positive results from this project will provide background information on which government and local school policy can be based and altered for the betterment of our youths.

Conditions

Sleep Deprivation

Keywords

sleep duration; blood pressure; adolescents; holiday

Outcome Measures

Primary Outcomes (1)

• Change in ambulatory systolic blood pressure during wakefulness across school holidays

  Change in average systolic blood pressure during wakefulness as measured by 24-hour ambulatory blood pressure monitoring

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

Secondary Outcomes (8)

• Changes in other ambulatory BP parameters

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

• Change in sleep duration

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

• Change in vigilance

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

• Change in impulsivity

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

• Change in trail-making test score

  From 1 week before holiday to 1 week after holidays, an average of 4 weeks.

Study Arms (2)

Sleep-deprived group

i. Self-reported time in bed (period from bedtime to get-up time) during school days of \<8 hours per day ii. Self-perceived insufficient sleep during school days

Normal sleep group

i. Self-reported time in bed during school days of \>=8 hours per day ii. Self-perceived sufficient sleep during school days

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from local primary and secondary schools. We will send invitation letters to Principals to ask them for their help with screening questionnaire distribution and assessment arrangements in their school. The screening questionnaire asks about children sleep pattern during school terms and holidays, sleep-related symptoms (e.g. snoring), and medical history to see whether they are eligible to participate. Eligible subjects will receive the study factsheet and written informed consent form. Subjects with parental consent will be enrolled in our study.

You may qualify if:

• Adolescents aged between 10-18 years;
• Written informed consent and assent obtained from parents and adolescents.
• Self-reported time in bed (period from bedtime to get-up time) during school days of \<8 hours per day
• Self-perceived insufficient sleep during school days
• Self-reported time in bed during school days of \>=8 hours per day
• Self-perceived sufficient sleep during school days

You may not qualify if:

• Obesity which is defined as a body mass index (BMI) ≥95th percentile (corresponding to a z score of 1.645) of the local reference.
• Subjects who are having sleep disorder for example insomnia and/or currently receiving treatment for sleep problems.
• Known medical or psychiatric conditions or use of current medication that may affect sleep and BP.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Paediatrics, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be collected with Salivette tubes for assessing the level of cortisol and cortisone, as a reflection of stress which on its own can influence both sleep pattern and BP. Participants will be asked to collect their saliva in the morning when they are wearing the BP monitor. Each subject will have to provide five saliva samples according to a fixed sampling protocol: (1) one hour before bedtime, (2) immediately after awakening, (3) 15 min after awakening, (4) 30 min after awakening, and (5) 45 min after awakening.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Albert M Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

HK (1)