Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT00488007
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 76.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Presbycusis	Device: Hearing aids used : PHONAK Savia and Valeo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Hearing aids Active	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)
Placebo Comparator: Inactive Hearing aids Hearing aids turned off	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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xavier PERROT	Lyon		France	69495

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Marc BONNEFOY, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT00488007
• Other Study ID Numbers: 2006.414
• First Posted: Jun 19, 2007
• Last Update Posted: Aug 30, 2016
• Last Verified: Dec 1, 2011

• Keywords provided by Hospices Civils de Lyon: Alzheimer disease; Cognitive impairment; Sensorineural hearing loss; Hearing aids
• Additional relevant MeSH terms: Presbycusis; Alzheimer Disease

Study Results

No Results Posted as of Aug 30, 2016