NCT04133688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 18, 2019

Last Update Submit

October 15, 2021

Conditions

Addiction

Keywords

mobile app, pilot study, addiction, sleep, ePRO

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Mobile application (ASC)

EXPERIMENTAL

mobile app / devise

Device: ASC

Paper diary

ACTIVE COMPARATOR

paper diary

Device: ASC

Interventions

ASCDEVICE

mobile app

Also known as: mobile application
Mobile application (ASC)Paper diary

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Benjamin Pitrat, MD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 21, 2019

Study Start

October 30, 2019

Primary Completion

October 6, 2020

Study Completion

October 6, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations

FR(1)