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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Disease
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

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