Clinical trial NCT04187885: Physical Activity Stress and Sleep in Adolescents
Official title: Effect of Physical Activity Program During Academic Stress on Adolescent Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Problem Behavior
Keywords: sleep
adolescent
physical activity
academic stress
Lead sponsor: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Sponsor class: OTHER
Collaborators: name: Biochimie Clinique LR99ES11
name: Department of Biochemistry, La Rabta Hospital, Tunisia.
name: Université de Toulon
First posted: 2019-12-05
Enrollment: 56
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: sleep Efficiency (%)
timeFrame: change from baseline at 4th night
Secondary outcomes:
measure: bedtime
timeFrame: change from baseline at 4th night
measure: total time in bed (minutes)
timeFrame: change from baseline at 4th night
measure: sleep onset latency (minutes)
timeFrame: change from baseline at 4th night
measure: wake after sleep onset
timeFrame: change from baseline at 4th night
measure: nubmer of awake >3 minutes
timeFrame: change from baseline at 4th night
measure: Sedentary activities
timeFrame: pre and post intervention:day 1 and day 4
measure: light activities
timeFrame: pre and post intervention:day 1 and day 4
measure: moderate to vigorous activities
timeFrame: pre and post intervention : day1 and day 4
measure: Energy expenditure (kilo calories)
timeFrame: pre and post intervention : day1 and day 4
measure: circadian phase (DLMO)
timeFrame: night 4
measure: Cortisol peak
timeFrame: day 5
measure: Stroop test
timeFrame: day 5
measure: Trail marking test
timeFrame: day 5
measure: Barrage test
timeFrame: day 5
measure: California verbal learning test.
timeFrame: day 5
measure: Energy intake
timeFrame: day 5
measure: Subjective appetite sensations
timeFrame: day 5
measure: Subjective sleepiness (Karolinska scale)
timeFrame: day 5
Other outcomes:
Locations:
Study officials:
affiliation: Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
name: Amani Kallel, PHD
role: PRINCIPAL_INVESTIGATOR
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