Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

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StatoCompletato

Sponsor

Hospices Civils de Lyon

TEST CLINICO: NCT00488007

BioSeek: nct00488007

Parole chiave

Astratto

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

Date

Ultimo verificato:	11/30/2011
Primo inviato:	06/17/2007
Iscrizione stimata inviata:	06/17/2007
Primo pubblicato:	06/18/2007
Ultimo aggiornamento inviato:	08/28/2016
Ultimo aggiornamento pubblicato:	08/29/2016
Data di inizio effettiva dello studio:	04/30/2007
Data di completamento primaria stimata:	05/31/2013
Data stimata di completamento dello studio:	08/31/2013

Condizione o malattia

Alzheimer Disease

Presbycusis

Intervento / trattamento

Device: Hearing aids used : PHONAK Savia and Valeo

Fase

Gruppi di braccia

Braccio	Intervento / trattamento
Experimental: Active Hearing aids Active
Placebo Comparator: Inactive Hearing aids Hearing aids turned off

Criteri di idoneità

Età idonea per lo studio	65 Years Per 65 Years
Sessi idonei allo studio	All
Accetta volontari sani	sì
Criteri	Inclusion Criteria: - > 65 year-old - Medical diagnosis of Alzheimer disease - 15 ≤ MMSE ≤ 25 - No hearing aids in the last 2 years - Motivated caregiver living with the patient - Sensorineural hearing loss Exclusion Criteria: - Beginning of an anticholinesterasic treatment in the last 6 months - Change in the anticholinesterasic treatment in the last 2 months

Risultato

Misure di esito primarie

1. Cognitive benefit evaluated thanks to the ADAS-Cog scale [Times of measurements: 0, 6th and 12th month]

Misure di esito secondarie

1. Cognitive scales: MMSE, Grober and Buschke, Digit symbol test [0, 6th and 12th month]

2. Behavioural scales: IADL, NPI [1st week, 3rd 6th 9th and 12th month]

3. Quality of life scales: Zarit scale and ADRQL [Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)]

4. Consumption questionnaire [monthly]