DeliriumPhase 1/2MELONCT02597231
Melatonin and Sleep in Preventing Delirium in the Hospital
A Phase 1/2 study testing Melatonin in people with Delirium, run by Scripps Health at 1 site in United States.
Trial summary
Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Delirium
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Dec 2016
- Phase
- Phase 1/2
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65-100 years old
- Admitted to Scripps Green Hospital
- Admitted to an Internal Medicine or Medicine Consult Service
- Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)
Who cannot join
- Cirrhosis of any etiology
- Admitted for alcohol withdrawal
- Currently taking a 1st or 2nd generation anti-psychotic
- Active delirium (i.e., delirium prior to 1st dose of melatonin)
- Diagnosis of encephalitis
- History of seizure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial
Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Melatonin is the dietary supplement we are using in delirium prevention.
PlaceboOther
Patients in this group will receive a matching placebo pill.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Experimental | Patients in this group will receive melatonin 3mg orally at 9pm. Receives: Dietary Supplement: Melatonin |
| Placebo Group | Placebo comparator | Patient in this group will receive a matching placebo pill orally at 9pm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium as measured by CAM Assessment
Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.
Measured: Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Secondary outcomes (4)
Objective Sleep Quality, measured by nocturnal sleep duration
Nocturnal sleep duration will be measured by wireless actigraphy.
Measured: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by number of nighttime wakenings
We will measure the number of nighttime wakenings using wireless actigraphy.
Measured: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by sleep latency
We will measure sleep latency (time to fall asleep) using wireless actigraphy.
Measured: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Subjective sleep quality, measured by Richards-Campbell sleep questionnaire
Patients will be asked to fill out the Richards-Campbell sleep question, which uses a visual analog scale for 5 questions that are designed to assess a patient's perceived sleep quality.
Measured: once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Scripps Clinic
- Responsible party
- Sponsor
- Investigators
- Thomas McCarthy, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597231
- Sponsor's protocol ID
- IRB-15-6639
- Acronym
- MELO
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2015
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13.
PubMed 33051948Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3.
PubMed 29729237
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02597231
- Acronym / sponsor ID
- MELO / IRB-15-6639
- Conditions
- Delirium
- Keywords
- Delirium, Melatonin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Scripps Clinic
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 Nov 2015 (estimated)
- 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.
Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin Group | Experimental | Dietary Supplement: MelatoninPatients in this group will receive melatonin 3mg orally at 9pm. |
| Placebo Group | Placebo comparator | Other: PlaceboPatient in this group will receive a matching placebo pill orally at 9pm. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65-100 years old
- Admitted to Scripps Green Hospital
- Admitted to an Internal Medicine or Medicine Consult Service
- Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)
Key exclusion criteria (6 listed)
- Cirrhosis of any etiology
- Admitted for alcohol withdrawal
- Currently taking a 1st or 2nd generation anti-psychotic
- Active delirium (i.e., delirium prior to 1st dose of melatonin)
- Diagnosis of encephalitis
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 |
|---|---|---|
| MelatoninMelatonin is the dietary supplement we are using in delirium prevention. | Dietary supplement | Melatonin Group |
| PlaceboPatients in this group will receive a matching placebo pill. | Other | Placebo Group |
Primary outcome
Delirium as measured by CAM Assessment
Time frame: Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.
4 secondary outcomes
Objective Sleep Quality, measured by nocturnal sleep duration
Time frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by number of nighttime wakenings
Time frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Objective sleep quality, measured by sleep latency
Time frame: nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Subjective sleep quality, measured by Richards-Campbell sleep questionnaire
Time frame: once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Derived from this study: PubMed 33051948Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13.
- Derived from this study: PubMed 29729237Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3.
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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.
Thomas McCarthy, MD principal investigator
Scripps Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melatonin in people with Delirium, run by Scripps Health 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 4 Oct 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delirium as measured by CAM Assessment (time frame: Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597231, which also lists 2 linked publications.
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 4 Oct 2017.