- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187885
Physical Activity Stress and Sleep in Adolescents (APADOSLEEP)
Effect of Physical Activity Program During Academic Stress on Adolescent Sleep
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Counterbalanced, cross-over, pre-post trial where each subject acts as his own control.
Four sessions will be performed for each adolescent. Each session will be conducted over 5 days (from Monday to Friday):
Adolescents will take part randomly in four sessions. Physical activity program will be identical between sessions and groups. 60 minn 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.
- Control session (CTL) outside academic stress period (represented by exams) and without the physical activity program.
- A session outside academic stress period, with the physical activity program (PAP).
- A session during an academic stress period without the physical activity program (AS).
- A session during an academic stress period with the physical activity program (ASPAP).
At each session:
- Continuous sleep assessments (duration and quality) by accelerometry
- Continuous physical activity and sedentary behaviour assessments by accelerometry
- one evaluation of melatonin peak from salivary specimens
- one evaluation of cortisol peak from salivary specimens
- An evaluation of the ad libitum food intake of the 5th day will be carried out by the weighing method.
- one assessment of cognitive performance
- An evaluation of subjective appetite sensations (hunger, fullness, desire to eat) of the 5th day
- An evaluation of subjective diurnal sleepiness (Karolinska) of the 5th day
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amani Kallel, PHD, HDR
- Phone Number: 0021696872787
- Email: kalamany2@gmail.com
Study Contact Backup
- Name: Moncef Feki
- Email: monssef.feki@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- college adolescent Tanner stages 3-5
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group/Cohort 1 : CTL
Label : control Type : comparator Description: Outside academic stress period (represented by exams), without the physical activity program (no Intervention). |
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.
Other Names:
|
Experimental: Group/Cohort 2: PAP
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. |
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.
Other Names:
|
Experimental: Group/Cohort 3: AS
Label : academic stress Type : experimental Description: during academic stress period (exams), without the physical activity program (no Intervention) |
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.
Other Names:
|
Experimental: Group/Cohort 4: ASPAP
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep Efficiency (%)
Time Frame: change from baseline at 4th night
|
the percentage of time spent asleep while in bed
|
change from baseline at 4th night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bedtime
Time Frame: change from baseline at 4th night
|
the time when the subjet goes to bed
|
change from baseline at 4th night
|
total time in bed (minutes)
Time Frame: change from baseline at 4th night
|
total time spent in bed
|
change from baseline at 4th night
|
sleep onset latency (minutes)
Time Frame: change from baseline at 4th night
|
actual time it takes to transition from wake to sleep in minutes
|
change from baseline at 4th night
|
wake after sleep onset
Time Frame: change from baseline at 4th night
|
awke after sleep has been initiated and before final awake
|
change from baseline at 4th night
|
nubmer of awake >3 minutes
Time Frame: change from baseline at 4th night
|
awkenings >3 minutes after sleep has been initiated and before final awake
|
change from baseline at 4th night
|
Sedentary activities
Time Frame: pre and post intervention:day 1 and day 4
|
time spent on Sedentary activities < 1Metabolic Equivalent of task (METs),
|
pre and post intervention:day 1 and day 4
|
light activities
Time Frame: pre and post intervention:day 1 and day 4
|
time spent on [1 - 3 ] expressed in Metabolic equivalent of task (METs)
|
pre and post intervention:day 1 and day 4
|
moderate to vigorous activities
Time Frame: pre and post intervention : day1 and day 4
|
time spent on moderate to vigorous activities [3 - 9 Metabolic equivalent of task[
|
pre and post intervention : day1 and day 4
|
Energy expenditure (kilo calories)
Time Frame: pre and post intervention : day1 and day 4
|
the amount of energy a person uses in the form of calories estimated by accelerometers
|
pre and post intervention : day1 and day 4
|
circadian phase (DLMO)
Time Frame: night 4
|
evaluations of melatonin peak from salivary specimens (5 measures), time (180, 120, 60 min before bedtime, bedtime and 60 min after bedtime)
|
night 4
|
Cortisol peak
Time Frame: day 5
|
evaluations of cortisol peak from salivary specimens (5 measures), (upon awakening, awakening + 30mn, awakening + 60mn, awakening + 120mn et awakening + 180mn)
|
day 5
|
Stroop test
Time Frame: day 5
|
selective attention and reading ability
|
day 5
|
Trail marking test
Time Frame: day 5
|
this test estimate visual attention and motor speed
|
day 5
|
Barrage test
Time Frame: day 5
|
this task evaluates visual- spatial ability and recognition
|
day 5
|
California verbal learning test.
Time Frame: day 5
|
this test evaluates primary and secondary memory
|
day 5
|
Energy intake
Time Frame: day 5
|
Energy intake and proportion of the energy derived from each class of macronutrients (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"
|
day 5
|
Subjective appetite sensations
Time Frame: day 5
|
hunger, fullness, desire to eat and prospective food consumption : upon awakening, before and right after the breakfast, lunch, snack and dinner as well as bed time. Appetite sensations will be collected throughout the day using visual analogue scales (150 mm scales). Adolescents will report their hunger, fullness, desire to eat and prospective food consumption at thirteen regulated times: upon awakening, before and right after the breakfast, lunch, snack and dinner as well as bed time. The questions were i) "How hungry do you feel?", ii) "How full do you feel?", iii) "Would you like to eat something?", iv) "How much do you think you can eat?" (adolescents were asked to respond on a scale from "not at all" to "a lot"). This method has been previously validated |
day 5
|
Subjective sleepiness (Karolinska scale)
Time Frame: day 5
|
this scale mesures the subjective level os sleepness at particular times during the day.
this is a nine point scale (1= extreemly alert, 3= alert, 5= neither nor sleepy, 7 = sleepy but no difficulty for main awake, 9= extreemly sleepy/ fighting sleep).
|
day 5
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amani Kallel, PHD, Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Publications and helpful links
General Publications
- 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.
- 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.
- Arora, T., and Grey, I. (2019). Sleep, obesity and cardiometabolic disease in children and adolescents. In Sleep and Health, (Elsevier), pp. 421-433.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- University Tunis El Manar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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