4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
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)
| Condition or disease |
|---|
| Alcohol Dependence Sleep Disorder |
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol |
| Actual Study Start Date : | January 15, 2012 |
| Actual Primary Completion Date : | January 15, 2013 |
| Actual Study Completion Date : | January 15, 2013 |
- 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.
- compare the duration of these 2 tests [ Time Frame: Day 1 ]duration (minutes, seconds)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 27, 2019 | ||||
| First Posted Date | July 5, 2019 | ||||
| Last Update Posted Date | July 8, 2019 | ||||
| Actual Study Start Date | January 15, 2012 | ||||
| Actual Primary Completion Date | January 15, 2013 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
||||
| Original Primary Outcome Measures |
to compare the SSI with a reference sleep questionnaire (Pittsburg Quality Sleep Index) in alcohol patients in different situations: Ambulatory or hospitalization,patients with active or abstinent consumption [ Time Frame: Day 1 ] scores
|
||||
| Change History | |||||
| Current Secondary Outcome Measures |
compare the duration of these 2 tests [ Time Frame: Day 1 ] duration (minutes, seconds)
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol | ||||
| Official Title | Validation of a Short Questionnaire (SSI) for Sleep Disorders in Patients With Alcohol | ||||
| Brief 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) |
||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with alcohol abuse or dependence | ||||
| Condition |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
100 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 15, 2013 | ||||
| Actual Primary Completion Date | January 15, 2013 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04007042 | ||||
| Other Study ID Numbers | IRB 12 05 04 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||
| Study Sponsor | Centre Hospitalier Universitaire de Nīmes | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Centre Hospitalier Universitaire de Nīmes | ||||
| Verification Date | July 2019 | ||||
