Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hospices Civils de Lyon.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00488007
First received: June 18, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | June 18, 2007 | ||||
| Last Updated Date | June 18, 2007 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Cognitive benefit evaluated thanks to the ADAS-Cog scale [ Time Frame: Times of measurements: 0, 6th and 12th month ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids | ||||
| Official Title ICMJE | Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-Economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis | ||||
| Brief Summary | This is a 12-months’ randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease. The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields. 2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Hearing aids used : PHONAK Savia and Valeo | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00488007 | ||||
| Other Study ID Numbers ICMJE | 2006.414 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospices Civils de Lyon | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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