A Controlled Study on Fighting Against Anxiety in Older People Through an Educational Audio Programme.

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

In residential care homes for the elderly, safeguarding the mental and emotional health of aged people is a key factor in their well-being and the quality of care they receive. Among these disorders, anxiety plays a central role. Furthermore, in aged people, anxiety is frequently associated with other psychological and functional vulnerabilities, notably depression and sleep disorders, with which it frequently interacts. Taken together, these factors contribute to a cycle of emotional, cognitive and functional vulnerability that can impair the well-being of residents in care homes. In light of these challenges, non-pharmacological interventions (NPIs), which have the potential to reduce anxiety and depression and improve sleep, represent a particularly promising complementary approach and are attracting growing interest in the care of aged people living in care homes. The Simone Veil Gerontology Institute and Care Home of Cannes Hospital wishes to offer its residents a sound immersion programme as part of their standard care. The audio content is sourced from the SOMEO Life digital platform, an audio-guided application accessible via wireless headphones connected to a tablet or smartphone, allowing for individual or group use. This application offers pre-recorded sessions on relaxation, guided breathing and sophrology tailored to aged people living in care homes. In this context, this study aims to explore and evaluate, within a pragmatic and institutional framework, the benefits of an audio-guided sound immersion programme (SOMEO Life platform) on the current levels of anxiety among residents living in care homes. Depressive symptoms, sleep disorders and the use of anti-anxiety medication will also be assessed.

An exploratory, prospective, single-centre, randomised, controlled, open-label study evaluating the benefits of a digital audio programme on anxiety in elderly people in care homes is implemented. Forty patients will be recruited (twenty per groups) and followed-up during 3 months.

Primary objective is to determine whether adding an audio-guided sound immersion programme to standard care reduces the current level of anxiety (state anxiety) in patients in residential care homes for the elderly. Study endpoint is State-Trait Anxiety Inventory (STAI-Y), specifically the State Anxiety (Y-A) subscale.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Residents who have been living in the care home for more than 2 months; · - A Mini Mental State Examination (MMSE) score of ≥ 20/30\*, obtained in routine clinical practice within the 6 months prior to enrolment;
• Patients with sufficient French language understanding, as assessed by the investigators
• Patient's consent to participate in the study;
• For patients under guardianship, curatorship or judicial protection, consent from the legal representative.
• Social security scheme affiliation

Exclusion Criteria:

• Patients with hearing loss who do not wear a hearing aid or whose hearing impairment prevents them from making effective use of the audio equipment;
• Patients who, in the investigator's opinion, are unable to understand the objectives of the study or meet its criteria

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Centre Hospitalier de Cannes Simone Veil

Study start

Jan 2, 2027 Estimated

Primary completion

Jun 2, 2028 Estimated

Study completion

Dec 31, 2028 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts