Clinical trial NCT05228769: Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program
Official title: Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acquired Deafness
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Sainte-Marie Hospital
First posted: 2022-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired hearing loss (mild, moderate, severe or profound), with hearing aid, participating in a complete rehabilitation program between November 2015 and June 2021.

Brief summary: In 2008, the Handicap-Santé survey counted 10 million people with hearing difficulties in France, i.e. 16% of the national population. For 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life.

In 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others.

Hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. It can also limit the quality of exchanges, communication and information taking.

Several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety.

Currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. Hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. However, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting.

Current treatment seems to deal mainly with auditory-cognitive problems. To date, no multidisciplinary rehabilitation services seem to be offered in France to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.


Eligibility criteria: Inclusion Criteria:

* Patients whose age ≥ 18 years
* Patients with acquired hearing loss (mild, moderate, severe or profound)
* Patients with hearing aids
* Patients participating in a complete rehabilitation program
* Patients who master the French language

Exclusion Criteria:

* Patients with proven cognitive impairment
* Implanted patients
* Patients under guardianship or curatorship
* Patients deprived of liberty
* Patients under court protection
* Interruption of the rehabilitation program before a minimum of 6 half-days of HDJ
* Patients objecting to the use of their data for this research

Primary outcomes:
measure: Impact of multidisciplinary rehabilitation on the quality of life of adults with hearing aids
timeFrame: Month 1
Secondary outcomes:
measure: Patient profile of age
timeFrame: Month 1
measure: Patient profile of type of hearing loss
timeFrame: Month 1
measure: Patient profile of severity
timeFrame: Month 1
measure: Quality of life of patients
timeFrame: Month 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Sainte-Marie
Study officials:
affiliation: Hôpital Sainte-Marie
name: Pierre SAFAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15.
citation: Brodie A, Smith B, Ray J. The impact of rehabilitation on quality of life after hearing loss: a systematic review. Eur Arch Otorhinolaryngol. 2018 Oct;275(10):2435-2440. doi: 10.1007/s00405-018-5100-7. Epub 2018 Aug 23.