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

Completed

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with alcohol abuse or dependence

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2012

Primary Completion (Actual)

January 15, 2013

Study Completion (Actual)

January 15, 2013

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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