Clincosm LogoSign in Get a demo

ASC-Val: Mobile App in Addiction

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT04133688
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
11.2
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

Condition or Disease Intervention/Treatment Phase
  • Device: ASC
 N/A

Detailed Description

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Mobile App for the Self Quantification of Sleep and Behaviors : a Pilot Study With Teenagers and Young Adults
Actual Study Start Date :
Oct 30, 2019
Actual Primary Completion Date :
Oct 6, 2020
Actual Study Completion Date :
Oct 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile application (ASC)

mobile app / devise

Device: ASC
mobile app
Other Names:
  • mobile application

    		•
    Active Comparator: Paper diary

    paper diary

    Device: ASC
    mobile app
    Other Names:
  • mobile application

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of days filled for sleep and consumptions, usable by the doctor on the day of the consultation / after 15 days of self-evaluation required by the treatment [15 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Teenagers or young adults from 12 to 18 years old (included)

    • Consultant for addiction to cannabis and / or tobacco and / or alcohol and / or screen

    • Treated within the Functional Unit of addictology

    • For minors, after parental consent

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert Debre Hospital Paris France 75019

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Benjamin Pitrat, MD, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04133688
    Other Study ID Numbers:
    • 2018-A01374-51
    First Posted:
    Oct 21, 2019
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    mobile app, pilot study, addiction, sleep, ePRO
    Additional relevant MeSH terms:
    Behavior, Addictive

    Study Results

    No Results Posted as of Oct 18, 2021