Not yet recruitingNAINTERVENTIONAL

Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)

This study, called "Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)", is exploring if music therapy can help people with Alzheimer's disease and similar conditions who live in secure care units. Some people with these conditions can become restless and confused in the evenings, a problem sometimes called 'sundowning syndrome'. The study aims to see if listening to music, led by a therapist, can help them fall asleep and feel calmer. Researchers will compare music interventions with listening to audiobooks. Each person will experience both the music and the audiobooks at different times, helping researchers understand which approach is more effective.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Sep 2027

Alzheimer Disease or Associated Disorder

What is this study about?

This study is designed to help people living with Alzheimer's disease or similar memory conditions who are experiencing difficulties in the evenings. Sometimes, as the day ends, people with these conditions can become agitated, confused, or have trouble sleeping. This is often referred to as 'sundowning syndrome'. The researchers want to find out if listening to music, guided by a therapist, can make a positive difference to these evening challenges.

The study involves comparing two different activities: listening to music or listening to an audiobook. Both of these will be led by a therapist in the participant's living area. The researchers want to see if one of these methods is better at helping people fall asleep more easily and feel more settled in the evenings. Because each person will try both the music and the audiobooks at different times, this means the researchers can get a really good idea of how each approach affects them.

Ultimately, by understanding what helps people with Alzheimer's and related conditions feel more at ease and sleep better, this research could lead to new, gentle ways to improve their quality of life, especially during what can be a difficult time of day.

Key takeaways

The study explores if music helps people with dementia sleep better and feel calmer.
It compares music interventions with listening to audiobooks.
Participants are residents of secure care units with Alzheimer's or related conditions.
A therapist will deliver the sessions directly in the living environment.
Your legal guardian must give consent for you to participate.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to be 60 years old or older and have a diagnosis of Alzheimer's disease or a similar memory condition. You would also need to be living in a secure care unit. For your involvement, your legal guardian would need to give their permission after understanding all the information about the study.

If you are currently taking any calming medicines or strong pain relief, these medications need to have been at a steady dose for a certain amount of time before you can join. This helps make sure the study results are clear and not affected by recent changes in your medication.

However, you wouldn't be able to join if you refuse to take part, are currently in another study that might affect your sleep or behaviour, or are very drowsy most of the time. Also, if you're very unwell, have certain strong false beliefs, or have been in your care unit for less than a month, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 60 years old or over?
Do you have a diagnosis of Alzheimer's disease or a similar memory condition?
Do you live in a secure care unit?
Is your legal guardian willing to give consent for you to join after understanding the study?
Have you been on a stable dose of any calming or strong pain relief medicines for the required time?
Are you able to participate without being overly drowsy or having severe active delusions?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have ten evening sessions where a therapist will guide you through either listening to music or listening to an audiobook. You will experience both of these activities during the study, but at different times. The order in which you have the music or the audiobook will be decided randomly, a bit like tossing a coin.

Before you start, during the sessions, and after each set of sessions, the care team will collect information about your behaviour and sleep patterns. This might involve observations from staff and possibly wearing a small device similar to a watch to track your sleep and activity. The total duration of your participation will include these two blocks of ten evening sessions, plus the time for observation before, during, and after.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as helping you feel calmer in the evenings or improving your sleep. However, we cannot guarantee any specific benefits for you personally. The risks involved are generally very low, as both music and audiobooks are gentle activities; there are no medications or invasive procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Saint-etienne hospital
Verified postcode
Saint-Etienne, France

Common questions

What is 'sundowning syndrome'?

It's when people with memory conditions become more confused, agitated, or restless as evening approaches.

Will I have to take any new medicines?

No, this study does not involve any new medications. It's about music and audiobooks.

Who will be with me during the sessions?

A therapist will be present to guide you through the music or audiobook sessions.

How long do the sessions last?

Each evening session with the therapist will be for a set period, though the exact length isn't specified, it's typically part of an evening routine.

Can I stop participating if I want to?

Yes, you or your legal guardian can decide to stop your participation at any time without any reason.

How to find out more

Isabelle ROUCH, MD

isabelle.rouch@chu-st-etienne.fr (0)477127399 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.