Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

Alzheimer Disease Clinical Trial

Official title:

Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488007
• Other study ID #: 2006.414
• Status: Completed
• Phase: N/A
• First received: June 18, 2007
• Last updated: August 29, 2016
• Start date: May 2007
• Est. completion date: September 2013

Study information

• Verified date: December 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Presbycusis

Intervention

Device:
• Hearing aids used : PHONAK Savia and Valeo
5 hours per day during the first 6 months (active or inactive upon randomization) 5 hours per day during the last 6 months (active)

Locations

Country	Name	City	State
France	Xavier PERROT	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive benefit evaluated thanks to the ADAS-Cog scale		Times of measurements: 0, 6th and 12th month	No
Secondary	Cognitive scales: MMSE, Grober and Buschke, Digit symbol test		0, 6th and 12th month	No
Secondary	Behavioural scales: IADL, NPI		1st week, 3rd 6th 9th and 12th month	No
Secondary	Quality of life scales: Zarit scale and ADRQL		Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month)	No
Secondary	Consumption questionnaire		monthly	Yes