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Physical Activity Stress and Sleep in Adolescents (APADOSLEEP)

Primary Purpose

Adolescent Problem Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group/Cohort 2: PAP
Sponsored by
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adolescent Problem Behavior focused on measuring sleep, adolescent, physical activity, academic stress

Eligibility Criteria

14 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Group/Cohort 1 : CTL

    Group/Cohort 2: PAP

    Group/Cohort 3: AS

    Group/Cohort 4: ASPAP

    Arm Description

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

    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.

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

    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.

    Outcomes

    Primary Outcome Measures

    sleep Efficiency (%)
    the percentage of time spent asleep while in bed

    Secondary Outcome Measures

    bedtime
    the time when the subjet goes to bed
    total time in bed (minutes)
    total time spent in bed
    sleep onset latency (minutes)
    actual time it takes to transition from wake to sleep in minutes
    wake after sleep onset
    awke after sleep has been initiated and before final awake
    nubmer of awake >3 minutes
    awkenings >3 minutes after sleep has been initiated and before final awake
    Sedentary activities
    time spent on Sedentary activities < 1Metabolic Equivalent of task (METs),
    light activities
    time spent on [1 - 3 ] expressed in Metabolic equivalent of task (METs)
    moderate to vigorous activities
    time spent on moderate to vigorous activities [3 - 9 Metabolic equivalent of task[
    Energy expenditure (kilo calories)
    the amount of energy a person uses in the form of calories estimated by accelerometers
    circadian phase (DLMO)
    evaluations of melatonin peak from salivary specimens (5 measures), time (180, 120, 60 min before bedtime, bedtime and 60 min after bedtime)
    Cortisol peak
    evaluations of cortisol peak from salivary specimens (5 measures), (upon awakening, awakening + 30mn, awakening + 60mn, awakening + 120mn et awakening + 180mn)
    Stroop test
    selective attention and reading ability
    Trail marking test
    this test estimate visual attention and motor speed
    Barrage test
    this task evaluates visual- spatial ability and recognition
    California verbal learning test.
    this test evaluates primary and secondary memory
    Energy intake
    Energy intake and proportion of the energy derived from each class of macronutrients (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"
    Subjective appetite sensations
    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
    Subjective sleepiness (Karolinska scale)
    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).

    Full Information

    First Posted
    September 20, 2019
    Last Updated
    December 3, 2019
    Sponsor
    Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
    Collaborators
    Biochimie Clinique LR99ES11, Department of Biochemistry, La Rabta Hospital, Tunisia., Université de Toulon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04187885
    Brief Title
    Physical Activity Stress and Sleep in Adolescents
    Acronym
    APADOSLEEP
    Official Title
    Effect of Physical Activity Program During Academic Stress on Adolescent Sleep
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 3, 2020 (Anticipated)
    Primary Completion Date
    November 28, 2021 (Anticipated)
    Study Completion Date
    March 3, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
    Collaborators
    Biochimie Clinique LR99ES11, Department of Biochemistry, La Rabta Hospital, Tunisia., Université de Toulon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Problem Behavior
    Keywords
    sleep, adolescent, physical activity, academic stress

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group/Cohort 1 : CTL
    Arm Type
    Active Comparator
    Arm Description
    Label : control Type : comparator Description: Outside academic stress period (represented by exams), without the physical activity program (no Intervention).
    Arm Title
    Group/Cohort 2: PAP
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group/Cohort 3: AS
    Arm Type
    Experimental
    Arm Description
    Label : academic stress Type : experimental Description: during academic stress period (exams), without the physical activity program (no Intervention)
    Arm Title
    Group/Cohort 4: ASPAP
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group/Cohort 2: PAP
    Other Intervention Name(s)
    Physial activity Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    sleep Efficiency (%)
    Description
    the percentage of time spent asleep while in bed
    Time Frame
    change from baseline at 4th night
    Secondary Outcome Measure Information:
    Title
    bedtime
    Description
    the time when the subjet goes to bed
    Time Frame
    change from baseline at 4th night
    Title
    total time in bed (minutes)
    Description
    total time spent in bed
    Time Frame
    change from baseline at 4th night
    Title
    sleep onset latency (minutes)
    Description
    actual time it takes to transition from wake to sleep in minutes
    Time Frame
    change from baseline at 4th night
    Title
    wake after sleep onset
    Description
    awke after sleep has been initiated and before final awake
    Time Frame
    change from baseline at 4th night
    Title
    nubmer of awake >3 minutes
    Description
    awkenings >3 minutes after sleep has been initiated and before final awake
    Time Frame
    change from baseline at 4th night
    Title
    Sedentary activities
    Description
    time spent on Sedentary activities < 1Metabolic Equivalent of task (METs),
    Time Frame
    pre and post intervention:day 1 and day 4
    Title
    light activities
    Description
    time spent on [1 - 3 ] expressed in Metabolic equivalent of task (METs)
    Time Frame
    pre and post intervention:day 1 and day 4
    Title
    moderate to vigorous activities
    Description
    time spent on moderate to vigorous activities [3 - 9 Metabolic equivalent of task[
    Time Frame
    pre and post intervention : day1 and day 4
    Title
    Energy expenditure (kilo calories)
    Description
    the amount of energy a person uses in the form of calories estimated by accelerometers
    Time Frame
    pre and post intervention : day1 and day 4
    Title
    circadian phase (DLMO)
    Description
    evaluations of melatonin peak from salivary specimens (5 measures), time (180, 120, 60 min before bedtime, bedtime and 60 min after bedtime)
    Time Frame
    night 4
    Title
    Cortisol peak
    Description
    evaluations of cortisol peak from salivary specimens (5 measures), (upon awakening, awakening + 30mn, awakening + 60mn, awakening + 120mn et awakening + 180mn)
    Time Frame
    day 5
    Title
    Stroop test
    Description
    selective attention and reading ability
    Time Frame
    day 5
    Title
    Trail marking test
    Description
    this test estimate visual attention and motor speed
    Time Frame
    day 5
    Title
    Barrage test
    Description
    this task evaluates visual- spatial ability and recognition
    Time Frame
    day 5
    Title
    California verbal learning test.
    Description
    this test evaluates primary and secondary memory
    Time Frame
    day 5
    Title
    Energy intake
    Description
    Energy intake and proportion of the energy derived from each class of macronutrients (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"
    Time Frame
    day 5
    Title
    Subjective appetite sensations
    Description
    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
    Time Frame
    day 5
    Title
    Subjective sleepiness (Karolinska scale)
    Description
    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).
    Time Frame
    day 5

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amani Kallel, PHD, HDR
    Phone
    0021696872787
    Email
    kalamany2@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moncef Feki
    Email
    monssef.feki@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amani Kallel, PHD
    Organizational Affiliation
    Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Arora, T., and Grey, I. (2019). Sleep, obesity and cardiometabolic disease in children and adolescents. In Sleep and Health, (Elsevier), pp. 421-433.
    Results Reference
    background
    PubMed Identifier
    21225346
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20093054
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12848225
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15737790
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25596964
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31100467
    Citation
    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.
    Results Reference
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    PubMed Identifier
    23851332
    Citation
    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.
    Results Reference
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    PubMed Identifier
    26447947
    Citation
    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.
    Results Reference
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    PubMed Identifier
    20113918
    Citation
    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.
    Results Reference
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    PubMed Identifier
    1538350
    Citation
    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.
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    Citation
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    Physical Activity Stress and Sleep in Adolescents

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