- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04007042
Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol
Sleep disorders are very common in alcohol patients (40-90% according to studies) These sleep disorders may persist after withdrawal and represent a major factor in relapse.
In a previous study, the investigators validated a simple sleep questionnaire (the "Short Sleep Index = SSI") from a multicentre series of 602 American patients (Perney et al., Alcohol Alcohol 2012) The SSI is obtained from the Hamilton score (baseline score for anxiety and depression)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria Sick people with alcohol abuse or dependence Inpatient or outpatient follow-up (Nîmes University Hospital, Grau du Roi Hospital, Montpellier, Centre de Soins d'Accompagnement et de Prévention en Addictologie (CSAPA of Nîmes University Hospital) Agreeing to answer the questionnaire Not having a cognitive deficit or psychiatric pathology that makes interrogation unreliable
- Exclusion criteria : NA
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index
Time Frame: Day 1
|
PQSI and SSI scores. PQSI : The overall score is obtained by summing the seven components. It goes from 0: "no difficulty" to 21: "major difficulties". A PSQI greater than 5 indicates sleep disturbances and ranks subjects as good and bad sleepers. |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare the duration of these 2 tests
Time Frame: Day 1
|
duration (minutes, seconds)
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 12 05 04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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