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What do sleep disorder patients and their caregivers really need? a new study aims to find out

NCT ID NCT07498452

Knowledge-focused Sponsor: Universita di Verona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study surveys 150 people with isolated REM sleep behavior disorder (iRBD) and their caregivers. iRBD causes people to act out dreams during sleep and is linked to future brain diseases. The study asks about their emotional well-being, access to information, and support needs. Results may help improve care and resources for these families.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors and researchers better support patients and families living with isolated REM sleep behavior disorder, improving education and care.
What could go wrong
This is an observational survey, not a treatment trial. It will not test any drug or therapy, so it cannot directly change disease outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults diagnosed with isolated REM Sleep Behavior Disorder (iRBD) recruited at participating sleep and movement disorders centers, and their significant others or caregivers. Patients are identified during routine clinical care and invited to participate in the study together with a family member or significant other. Both patients and caregivers complete structured questionnaires assessing informational needs, psychosocial impact, and experiences related to the diagnosis and management of iRBD.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with iRBD according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. * Patients who have had a follow-up visit within the previous 12 months. * Patients who provide informed consent to participate in the study. * Partners/family members of patients with iRBD who accept to participate. Exclusion Criteria: * Patients with RBD who have already phenoconverted to a neurodegenerative disorder. * Patients or partners/family members without access to an email address.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

REM sleep behavior disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Isolated rem sleep behavior disorder Rem sleep behavior disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Tuscany, 56124, Italy

  • Azienda Ospedaliero-Universitaria di Cagliari

    RECRUITING

    Cagliari, Sardinia, 09124, Italy

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • I.R.C.C.S. Associazione Oasi Maria SS. - Ospedale Classificato

    RECRUITING

    Troina, Sicily, 94018, Italy

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    RECRUITING

    Bologna, Emilia-Romagna, 40139, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genoa, Liguria, 16132, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Lombardy, 20132, Italy

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