Clinical trial NCT02390583: Internet Addiction and Sleep Disorders
Official title: Internet Addiction and Sleep Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Internet Addiction
Keywords: Internet dependence
Sleep disorders
pathological gambling
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

Detailed description: We will check sleep disorders among patients presenting internet dependence. Diagnosis will be followed by a specific treatment during three months. This treatment is expected to reduce prevalence of internet dependence and associated addictive disorders (alchohol, nicotine) . rate of sleep disorders is also expected to decrease under treatment.

This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

Patients will be randomised in two arms : controls (CBT treatment of Internet dependence) and intervention (CBT treatment of addiction plus CBT treatment of sleep disorders).

Eligibility criteria: Inclusion Criteria:

* Internet addiction (Young scale ≥5)
* Online compulsive gambling ( DSM IV scale for pathological gambling and SOGS) and/or addiction to online gaming (problem video game playing ≥ 5)
* sleep latency \>45 min/night and more than 3 nights a week
* subjective total sleep time \<6h30/night more than 3 nights a week
* Adult patient

Exclusion Criteria:

* cognitive impairments, memory disorders, non french-speaking patients
* already known and on treatment sleep pathologies
* somatic conditions non compatible with clinical evaluation
* cybersex dependance
* Treatment with dopaminergic agents
* patients under jurisdictional assistance
* patients non covered by the french health system
* non consenting patients
* History of Healthcare for internet dependence
* Patients already treated for internet dependance
* pregnant or lactating women
* Patients already participating in other studies on internet dependance and sleeping disorders
* suicide attempt before inclusion

Primary outcomes:
measure: number of hours each week spent gaming or online gambling
timeFrame: 6 months
Secondary outcomes:
measure: Number of hours spent on line gaming or online gambling
timeFrame: 3 months
measure: insomnia
timeFrame: 3 and 6months
measure: daytime sleepiness
timeFrame: 3 and 6 months
measure: total sleep time
timeFrame: 3 and 6 months
measure: number of awakenings during night
timeFrame: 3 and 6 months
measure: treatment with hypnotics
timeFrame: 3 and 6 months
measure: Depression
timeFrame: 3 and 6 months
measure: Anxiety
timeFrame: 3and 6 months
measure: Alcohol dependence
timeFrame: 3 and 6 months
measure: Nicotine Dependence
timeFrame: 3 and 6 months
measure: Other psychoactive agents
timeFrame: 3 and 6 months
measure: Compliance
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat-Claude.Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Lejoyeux Lejoyeux, Professor
role: PRINCIPAL_INVESTIGATOR
References: