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Sleep disorder drugs may impact heart and mind – new study investigates

NCT ID NCT05371483

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Mayo Clinic study will follow 100 adults with narcolepsy or idiopathic hypersomnia who are starting a new treatment. Researchers will measure changes in blood pressure over 24 hours and track eye movements during a simple mental test before and after at least 3 months on medication. The goal is to understand how common treatments affect both the heart and the brain.

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 choose safer treatments for narcolepsy and idiopathic hypersomnia by understanding their effects on blood pressure and thinking skills.
What could go wrong
This is an observational study, not a treatment trial. It will not test whether a drug works, only measure changes. Results may not apply to everyone.

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 100 people

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

Started

May 2022

Expected to finish

Jul 2028

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

Patients diagnosed with narcolepsy or idiopathic hypersomnia that have been prescribed but not yet started a new/different hypersomnia medication.

Ages

18 to 75 years

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: * Diagnosed with narcolepsy or idiopathic hypersomnia according to International Classification of Sleep Disorders, third edition * Age 18 - 75 years * BMI between 18 and 40 kg/m2 * Prescribed a medication of interest (e.g., sodium oxybate, low sodium oxybate, pitolisant, modafinil/armodafinil, solriamfetol, traditional stimulant(s)) by a clinical sleep specialist as part of routine medical care. * Subject must be willing to postpone starting medication until after completion of baseline assessment(s). * If subject has been taking a prescribed hypersomnia medication(s) at a stable dose for at least 3 months and has been prescribed a new medication, then subject may complete baseline assessment(s) while taking initial hypersomnia medication(s) before starting new medication. Exclusion Criteria: * Any change to medication(s) within the last 45 days * History of chronic alcohol or drug abuse within the prior 12 months * Heart failure, history of severe hypertension, or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study * Use of any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.) within 45 days of baseline assessment visit * Participation in another study of an investigational drug within the 28 days prior to screening visit or currently * Pregnancy and/or breast-feeding * Subjects who, in the opinion of the Investigator, may not be suitable for the study.

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Conditions

The condition(s) this trial relates to.

idiopathic hypersomnia narcolepsy

As listed by the trial registrant

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

Idiopathic hypersomnia Narcolepsy

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.