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NCT04007042 Clinical Trial

Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol

Alcohol Dependence Clinical Trial

Official title:
Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04007042
Other study ID # IRB 12 05 04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2012
Est. completion date January 15, 2013

Study information
Verified date July 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)

Description:

to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index) in alcohol patients in different situations: Ambulatory or hospitalization

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 15, 2013
Est. primary completion date January 15, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome
Type Measure Description Time frame Safety issue
Primary to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index 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 compare the duration of these 2 tests duration (minutes, seconds) Day 1
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