Auditory Rehabilitation and Cognition in Alzheimer Patients
Parole chiave
Astratto
Date
| Ultimo verificato: | 10/31/2019 |
| Primo inviato: | 03/15/2016 |
| Iscrizione stimata inviata: | 12/19/2016 |
| Primo pubblicato: | 12/22/2016 |
| Ultimo aggiornamento inviato: | 11/03/2019 |
| Ultimo aggiornamento pubblicato: | 11/04/2019 |
| Data di inizio effettiva dello studio: | 03/30/2017 |
| Data di completamento primaria stimata: | 03/29/2020 |
| Data stimata di completamento dello studio: | 05/29/2020 |
Condizione o malattia
Intervento / trattamento
Device: Patients treated with hearing aids
Device: Patients treated with placebo device
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Experimental: Patients treated with hearing aids Patients fitted with functional hearing aids (Phonak Audéo BR) | Device: Patients treated with hearing aids Phonak Audéo B-R (Target V 5.0) |
| Placebo Comparator: Patients treated with placebo device Patients fitted with non-functional hearing aids | Device: Patients treated with placebo device Phonak Audéo B-R (Target V 5.0) without amplification |
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: - Alzheimer patient - Mini Mental state examination= 15-25 or mild cognitive impairment - Over 65 yo - Sensorineural hearing loss with pure tone average over 30 dB - Language: French - Able to sign the consent - Affiliated to the French social security Exclusion Criteria: - Conductive hearing loss - Retrocochlear hearing loss - History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness) - patient included in another study - French no spoken - chronic used of drugs or alcohol |
Risultato
Misure di esito primarie
1. Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale [Change before and one year after the fitting with device]
Misure di esito secondarie
1. air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
2. Speech recognition threshold (dB HL) measured by speech audiometry [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
3. Speech Discrimination Test (%) measured by speech audiometry [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
4. Dichotic test measured with audiometry [From 1 to 90 days prior the fitting with device]
5. Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL) [6 months after the fitting with device, 12 months after the fitting with device]
6. Devices tolerance measured with number of hours per day with hearing aids [6 months after the fitting with device, 12 months after the fitting with device]
7. Objective auditory thresholds measured with auditory brainstem responses (ms) [6 months after the fitting with device, 12 months after the fitting with device]
8. Objective auditory thresholds measured by Auditory steady state responses (in dB eHL) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
9. Mini Mental State Examination (30 items, total score from 0-30) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
10. Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
11. Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
12. Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
13. Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
14. Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30) [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
15. Executive functions measured by trail making test [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
16. Working memory and processing speed measured by Wechsler Adult Intelligence Scale [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
17. Speech comprehension measured by Beauregard tests [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
18. Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire [From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device]
