Rapid Eye Movement Sleep Behavior DisorderNCT05307770
Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
A study testing Immediate Release Melatonin and Extended Release Melatonin in people with Rapid Eye Movement Sleep Behavior Disorder and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Eye Movement Sleep Behavior Disorder, Parkinson Disease
- What is being tested?
- Immediate Release Melatonin and Extended Release Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
- Patient registered to Parkinson's disease database of Mayo Clinic Florida.
Who cannot join
- Patients who are using other sleep aids or medications (Clonazepam).
- Patients who are not willing to undertake 1 week of washout period.
- Patients who do not sign a consent for research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.
Read the detailed description
Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.
- Being tested
- Immediate Release Melatonin, Extended Release Melatonin
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Release MelatoninDietary supplement
5 mg orally every night at 9 pm for 4 weeks
Extended Release MelatoninDietary supplement
5 mg orally every night at 9 pm for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Immediate Release Melatonin, Then Extended Release Melatonin | Experimental | Subjects will receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. Receives: Dietary Supplement: Immediate Release Melatonin; Dietary Supplement: Extended Release Melatonin |
| Extended Release Melatonin, Then Immediate Release Melatonin | Experimental | Subjects will receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. Receives: Dietary Supplement: Immediate Release Melatonin; Dietary Supplement: Extended Release Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep cycle
Assessed by the self-reported modified Mayo Sleep questionnaire (MSQ) which consists of 8 questions related to sleep behavior in the past month.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 May 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Eye Movement Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emir Festic, Mayo Clinic
- Investigators
- Emir Festic, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307770
- Sponsor's protocol ID
- 21-003326
- Status last verified
- May 2024
- First submitted
- 23 Mar 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT05307770
- Acronym / sponsor ID
- 21-003326
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.
Detailed description
Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Release Melatonin, Then Extended Release Melatonin | Experimental | Dietary Supplement: Immediate Release Melatonin, Dietary Supplement: Extended Release MelatoninSubjects will receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. |
| Extended Release Melatonin, Then Immediate Release Melatonin | Experimental | Dietary Supplement: Immediate Release Melatonin, Dietary Supplement: Extended Release MelatoninSubjects will receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
- Patient registered to Parkinson's disease database of Mayo Clinic Florida.
Key exclusion criteria (3 listed)
- Patients who are using other sleep aids or medications (Clonazepam).
- Patients who are not willing to undertake 1 week of washout period.
- Patients who do not sign a consent for research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Release Melatonin5 mg orally every night at 9 pm for 4 weeks | Dietary supplement | Extended Release Melatonin, Then Immediate Release Melatonin, Immediate Release Melatonin, Then Extended Release Melatonin |
| Extended Release Melatonin5 mg orally every night at 9 pm for 4 weeks | Dietary supplement | Extended Release Melatonin, Then Immediate Release Melatonin, Immediate Release Melatonin, Then Extended Release Melatonin |
Primary outcome
Change in sleep cycle
Time frame: Baseline and 4 weeks
Assessed by the self-reported modified Mayo Sleep questionnaire (MSQ) which consists of 8 questions related to sleep behavior in the past month.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Festic, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Release Melatonin and Extended Release Melatonin in people with Rapid Eye Movement Sleep Behavior Disorder and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep cycle (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.