Adolescent Problem BehaviorAPADOSLEEPNCT04187885
Physical Activity Stress and Sleep in Adolescents
A study testing Group/Cohort 2: PAP in people with Adolescent Problem Behavior, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Problem Behavior
- What is being tested?
- Group/Cohort 2: PAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2020to 3 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- college adolescent Tanner stages 3-5
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Moncef Feki contact
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Adolescent Problem Behavior
- Being tested
- Group/Cohort 2: PAP
- Keywords
- sleep, adolescent, physical activity, academic stress
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group/Cohort 2: PAPBehavioural
Also called Physial activity Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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) Receives: 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. Receives: Behavioral: Group/Cohort 2: PAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep Efficiency (%)
the percentage of time spent asleep while in bed
Measured: change from baseline at 4th night
Secondary outcomes (18)
bedtime
the time when the subjet goes to bed
Measured: change from baseline at 4th night
total time in bed (minutes)
total time spent in bed
Measured: change from baseline at 4th night
sleep onset latency (minutes)
actual time it takes to transition from wake to sleep in minutes
Measured: change from baseline at 4th night
wake after sleep onset
awke after sleep has been initiated and before final awake
Measured: change from baseline at 4th night
nubmer of awake >3 minutes
awkenings >3 minutes after sleep has been initiated and before final awake
Measured: change from baseline at 4th night
Sedentary activities
time spent on Sedentary activities < 1Metabolic Equivalent of task (METs),
Measured: pre and post intervention:day 1 and day 4
light activities
time spent on [1 - 3 ] expressed in Metabolic equivalent of task (METs)
Measured: pre and post intervention:day 1 and day 4
moderate to vigorous activities
time spent on moderate to vigorous activities [3 - 9 Metabolic equivalent of task[
Measured: pre and post intervention : day1 and day 4
Energy expenditure (kilo calories)
the amount of energy a person uses in the form of calories estimated by accelerometers
Measured: pre and post intervention : day1 and day 4
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)
Measured: night 4
Cortisol peak
evaluations of cortisol peak from salivary specimens (5 measures), (upon awakening, awakening + 30mn, awakening + 60mn, awakening + 120mn et awakening + 180mn)
Measured: day 5
Stroop test
selective attention and reading ability
Measured: day 5
Trail marking test
this test estimate visual attention and motor speed
Measured: day 5
Barrage test
this task evaluates visual- spatial ability and recognition
Measured: day 5
California verbal learning test.
this test evaluates primary and secondary memory
Measured: day 5
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"
Measured: day 5
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
Measured: day 5
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).
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start3 Sep 2020 (estimated)
- Primary completion28 Nov 2021 (estimated)
- Study completion3 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Adolescent Problem BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
- Sponsor type
- University, hospital or other
- Collaborators
- Biochimie Clinique LR99ES11, Department of Biochemistry, La Rabta Hospital, Tunisia., Université de Toulon
- Responsible party
- Sponsor
- Investigators
- Amani Kallel, PHD, Principal investigator, Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187885
- Sponsor's protocol ID
- University Tunis El Manar
- Acronym
- APADOSLEEP
- Status last verified
- Dec 2019
- First submitted
- 20 Sep 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21225346Dewald 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.
PubMed 20093054Haugland 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.
PubMed 12848225Ivanenko 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.
PubMed 15737790Kredlow 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.
PubMed 25596964Krietsch 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.
PubMed 31100467Lang 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.
PubMed 23851332Lang 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.
PubMed 26447947Lund 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.
PubMed 20113918Norris 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.
PubMed 1538350Stepanski 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.
PubMed 12927121
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity Program During Academic Stress on Adolescent Sleep
- ClinicalTrials.gov ID
- NCT04187885
- Acronym / sponsor ID
- APADOSLEEP / University Tunis El Manar
- Conditions
- Adolescent Problem Behavior
- Keywords
- sleep, adolescent, physical activity, academic stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'AthéroscléroseUniversity, hospital or other
- Collaborators
- Biochimie Clinique LR99ES11, Department of Biochemistry, La Rabta Hospital, Tunisia., Université de Toulon
- Study start
- 3 Sep 2020 (estimated)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 3 Mar 2022 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort 1 : CTL | Active comparator | Behavioral: Group/Cohort 2: PAPLabel : control Type : comparator Description: Outside academic stress period (represented by exams), without the physical activity program (no Intervention). |
| Group/Cohort 2: PAP | Experimental | Behavioral: Group/Cohort 2: PAPLabel : 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. |
| Group/Cohort 3: AS | Experimental | Behavioral: Group/Cohort 2: PAPLabel : academic stress Type : experimental Description: during academic stress period (exams), without the physical activity program (no Intervention) |
| Group/Cohort 4: ASPAP | Experimental | Behavioral: Group/Cohort 2: PAPLabel : 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- college adolescent Tanner stages 3-5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group/Cohort 2: PAPAlso: Physial activity ProgramEach 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. | Behavioural | Group/Cohort 1 : CTL, Group/Cohort 2: PAP, Group/Cohort 3: AS, Group/Cohort 4: ASPAP |
Primary outcome
sleep Efficiency (%)
Time frame: change from baseline at 4th night
the percentage of time spent asleep while in bed
18 secondary outcomes
bedtime
Time frame: change from baseline at 4th night
total time in bed (minutes)
Time frame: change from baseline at 4th night
sleep onset latency (minutes)
Time frame: change from baseline at 4th night
wake after sleep onset
Time frame: change from baseline at 4th night
nubmer of awake >3 minutes
Time frame: change from baseline at 4th night
Sedentary activities
Time frame: pre and post intervention:day 1 and day 4
light activities
Time frame: pre and post intervention:day 1 and day 4
moderate to vigorous activities
Time frame: pre and post intervention : day1 and day 4
Energy expenditure (kilo calories)
Time frame: pre and post intervention : day1 and day 4
circadian phase (DLMO)
Time frame: night 4
Cortisol peak
Time frame: day 5
Stroop test
Time frame: day 5
Trail marking test
Time frame: day 5
Barrage test
Time frame: day 5
California verbal learning test.
Time frame: day 5
Energy intake
Time frame: day 5
Subjective appetite sensations
Time frame: day 5
Subjective sleepiness (Karolinska scale)
Time frame: day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- BackgroundArora, T., and Grey, I. (2019). Sleep, obesity and cardiometabolic disease in children and adolescents. In Sleep and Health, (Elsevier), pp. 421-433.
- Background: PubMed 21225346Colrain 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.
- Background: PubMed 20093054Dewald 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.
- Background: PubMed 12848225Haugland 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.
- Background: PubMed 15737790Ivanenko 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.
- Background: PubMed 25596964Kredlow 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.
- Background: PubMed 31100467Krietsch 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.
- Background: PubMed 23851332Lang 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.
- Background: PubMed 26447947Lang 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.
- Background: PubMed 20113918Lund 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.
- Background: PubMed 1538350Norris 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.
- Background: PubMed 12927121Stepanski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moncef Feki contact
Amani Kallel, PHD principal investigator
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Questions about this trial
What is this clinical trial studying?
A study testing Group/Cohort 2: PAP in people with Adolescent Problem Behavior, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amani Kallel, PHD, HDR (0021696872787, kalamany2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep Efficiency (%) (time frame: change from baseline at 4th night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187885, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.