NCT04187885

Brief Summary

Adolescence is characterized by major transitions in sleep and circadian rhythm. This rapid pivotal period increases the risks of sleep debt and poor sleep quality, leading to pronounced diurnal fatigue and drowsiness. On the other hand, academic stress has been also associated with increased sleep disturbances. Both academic stress and poor sleep in adolescents has been linked to increased sleepiness rate, reduced alertness, lower academic performances and the impairment of the control of energy balance through hyperphagia. Despite the importance of sleep in holistic development, physical (i.e. recovery, metabolism, muscle growth, weight control), cognitive (i.e. learning, memory, decision-making, Vigilance). Few studies have been designed to improve this behavior among college adolescents, especially in times of academic stress. Physical activity has been suggested as a non-pharmacological alternative treatment for sleep disorders . Generally, it is well established that the duration and quality of sleep were improved by regular physical activity among adolescents and far better, it was suggested that the exercise-mediated effect on sleep could be even observed in the short term. Moreover, it was suggested that aerobic exercise has positive effects on psychological stress and well-being of adolescents . Therefore, APADOSLEEP trial, was designed to examine the effect of physical activity program on sleep during and outside periods of academic stress.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

September 20, 2019

Last Update Submit

December 3, 2019

Conditions

Adolescent Problem Behavior

Keywords

sleepadolescentphysical activityacademic stress

Outcome Measures

Primary Outcomes (1)

  • sleep Efficiency (%)

    the percentage of time spent asleep while in bed

    change from baseline at 4th night

Secondary Outcomes (18)

  • bedtime

    change from baseline at 4th night

  • total time in bed (minutes)

    change from baseline at 4th night

  • sleep onset latency (minutes)

    change from baseline at 4th night

  • wake after sleep onset

    change from baseline at 4th night

  • nubmer of awake >3 minutes

    change from baseline at 4th night

  • +13 more secondary outcomes

Study Arms (4)

Group/Cohort 1 : CTL

ACTIVE COMPARATOR

Label : control Type : comparator Description: Outside academic stress period (represented by exams), without the physical activity program (no Intervention).

Behavioral: Group/Cohort 2: PAP

Group/Cohort 2: PAP

EXPERIMENTAL

Label : physical activity program without stress Type : experimental Description: outside academic stress period (exams), with the physical activity program:60 min of mederate to vigorous leisure activities and exercises will be proposed from Monday to Thursday.

Behavioral: Group/Cohort 2: PAP

Group/Cohort 3: AS

EXPERIMENTAL

Label : academic stress Type : experimental Description: during academic stress period (exams), without the physical activity program (no Intervention)

Behavioral: Group/Cohort 2: PAP

Group/Cohort 4: ASPAP

EXPERIMENTAL

Label : academic stress and physical activity program Type : experimental Description: during academic stress period (exams), with the physical activity program: 60 min of mederate to vigorous leisure activities and exercises will be proposed from Monday to Thursday.

Behavioral: Group/Cohort 2: PAP

Interventions

Group/Cohort 2: PAPBEHAVIORAL

Each experimental session will be carried out over 5 days of a week. Adolescents will take part randomly in four sessions. Physical activity program will be identical between sessions and groups. 60 min of moderate to vigorous leisure activities and exercises will be proposed each day. Heart rate monitor will be used to control intensity of exercise during the physical activity program.

Also known as: Physial activity Program
Group/Cohort 1 : CTLGroup/Cohort 2: PAPGroup/Cohort 3: ASGroup/Cohort 4: ASPAP

Eligibility Criteria

Age14 Years - 18 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • college adolescent Tanner stages 3-5

You may not qualify if:

  • Disorders and / or pathology of sleep
  • Medical or surgical history not compatible with the study, any other chronic illness or injury that may interfere with the subject's abilities
  • Take medication that may interfere with the results of the study (corticosteroids ...) or sleeping pills
  • Surgical intervention in the previous 3 months
  • Regular consumption of tobacco, cannabis or alcohol
  • Special diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Arora, T., and Grey, I. (2019). Sleep, obesity and cardiometabolic disease in children and adolescents. In Sleep and Health, (Elsevier), pp. 421-433.

    BACKGROUND

  • Colrain IM, Baker FC. Changes in sleep as a function of adolescent development. Neuropsychol Rev. 2011 Mar;21(1):5-21. doi: 10.1007/s11065-010-9155-5. Epub 2011 Jan 12.

    PMID: 21225346BACKGROUND

  • Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bogels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21.

    PMID: 20093054BACKGROUND

  • Haugland S, Wold B, Torsheim T. Relieving the pressure? The role of physical activity in the relationship between school-related stress and adolescent health complaints. Res Q Exerc Sport. 2003 Jun;74(2):127-35. doi: 10.1080/02701367.2003.10609074.

    PMID: 12848225BACKGROUND

  • Ivanenko A, Crabtree VM, Gozal D. Sleep and depression in children and adolescents. Sleep Med Rev. 2005 Apr;9(2):115-29. doi: 10.1016/j.smrv.2004.09.006.

    PMID: 15737790BACKGROUND

  • Kredlow MA, Capozzoli MC, Hearon BA, Calkins AW, Otto MW. The effects of physical activity on sleep: a meta-analytic review. J Behav Med. 2015 Jun;38(3):427-49. doi: 10.1007/s10865-015-9617-6. Epub 2015 Jan 18.

    PMID: 25596964BACKGROUND

  • Krietsch KN, Chardon ML, Beebe DW, Janicke DM. Sleep and weight-related factors in youth: A systematic review of recent studies. Sleep Med Rev. 2019 Aug;46:87-96. doi: 10.1016/j.smrv.2019.04.010. Epub 2019 Apr 23.

    PMID: 31100467BACKGROUND

  • Lang C, Brand S, Feldmeth AK, Holsboer-Trachsler E, Puhse U, Gerber M. Increased self-reported and objectively assessed physical activity predict sleep quality among adolescents. Physiol Behav. 2013 Aug 15;120:46-53. doi: 10.1016/j.physbeh.2013.07.001. Epub 2013 Jul 9.

    PMID: 23851332BACKGROUND

  • Lang C, Kalak N, Brand S, Holsboer-Trachsler E, Puhse U, Gerber M. The relationship between physical activity and sleep from mid adolescence to early adulthood. A systematic review of methodological approaches and meta-analysis. Sleep Med Rev. 2016 Aug;28:32-45. doi: 10.1016/j.smrv.2015.07.004. Epub 2015 Aug 5.

    PMID: 26447947BACKGROUND

  • Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3.

    PMID: 20113918BACKGROUND

  • Norris R, Carroll D, Cochrane R. The effects of physical activity and exercise training on psychological stress and well-being in an adolescent population. J Psychosom Res. 1992 Jan;36(1):55-65. doi: 10.1016/0022-3999(92)90114-h.

    PMID: 1538350BACKGROUND

  • Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. doi: 10.1053/smrv.2001.0246.

    PMID: 12927121BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Amani Kallel, PHD

    Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amani Kallel, PHD, HDR

CONTACT

0021696872787kalamany2@gmail.com

Moncef Feki

CONTACT

monssef.feki@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2019

First Posted

December 5, 2019

Study Start

September 3, 2020

Primary Completion

November 28, 2021

Study Completion

March 3, 2022

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share