Could a sleep aid also ease Parkinson's movement problems?
NCT ID NCT07384429
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the sleep medication lemborexant can improve both sleep and motor symptoms in people with Parkinson's disease. Forty-four participants will take either lemborexant or a placebo nightly for 28 days. Researchers will measure changes in sleep quality and movement ability using standard Parkinson's rating scales.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lemborexant
- What this could lead to
- If it works, this could point toward a new way to help Parkinson's patients sleep better and possibly move more easily during the day.
- What could go wrong
- This is a small, early-phase trial with only 44 people. It may not show clear benefits, and lemborexant can cause side effects like drowsiness or dizziness.
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.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 1\. Aged 50 years or older; * 2\. Diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (2015), with a Hoehn \& Yahr stage of 1 to 4; * 3\. Disease duration of ≥ 2 years since diagnosis, clinically stable, and able to comply with the research assessments and interventions; * 4\. Diagnosis of insomnia disorder meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with an Insomnia Severity Index (ISI) score of ≥ 15; * 5\. Stable medication regimen for at least 4 weeks prior to the study; * 6\. Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study. Exclusion Criteria: * 1\. History of or diagnosis with a severe psychiatric disorder, such as depression, anxiety disorders, schizophrenia spectrum disorders, or bipolar disorder; * 2\. Presence of a clinically defined neurological disorder (assessed via self-report), including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, history of stroke, transient ischemic attack within the past 2 years, cerebral aneurysm, dementia, or multiple sclerosis; * 3\. Severe cognitive impairment (Mini-Mental State Examination (MMSE) score below 24) or inability to complete questionnaires independently; * 4\. Chronic obstructive pulmonary disease (COPD) or any lifelong history of sleep-related breathing disorders, such as sleep apnea; * 5\. Excessive daytime sleepiness, defined as self-reported daily daytime napping ≥ 1 hour per day on ≥ 3 days per week; * 6\. Regular caffeine consumption; * 7\. Use of any orexin receptor related medication within the past 3 months. * 8\. Previous history of cataplexy or known reduced orexin levels; * 9\. Inability to read or understand Chinese; * 10\. Use of other sleep-promoting medications within the past 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhongnan hospital
Wuhan, Hubei, 430000, China
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Other studies related to the condition(s) this trial covers.
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- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.