Sleep Initiation and Maintenance DisordersPhase 2NCT00230737
Effects of Melatonin on Insomnia Symptoms in Older Adults
A Phase 2 study testing Melatonin 0.4 mg and Melatonin 4.0 mg in people with Sleep Initiation and Maintenance Disorders, run by Nalaka Gooneratne at 1 site in United States.
Trial summary
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Melatonin 0.4 mg and Melatonin 4.0 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- History of insomnia
- Low melatonin levels at study entry
Who cannot join
- History of sleep apnea (temporary cessation of breathing during sleep)
- Diagnosis of restless legs syndrome
- Current alcohol or substance abuse
- Dementia
- Anemia
- Liver disease
- Leukemia or lymphoma
- Asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Melatonin Randomized Trial for Insomnia in the Elderly
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.
Read the detailed description
Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. Data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. Generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep.
Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of Week 1 and the end of Week 6. At study entry, participants will be admitted to the General Clinical Research Center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. During Night 1 at the clinic, participants will have urine samples collected throughout the night. Night 2 will be an adaptation night to allow participants to get used to their surroundings. On Night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. Participants with sleep efficiencies of 80% or higher will complete their study participation. Participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. Participants will have study visits at Weeks 1, 3, and 6 to monitor for adverse events. After 6 weeks, participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study. Sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. One month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.
- Being tested
- Melatonin 0.4 mg, Melatonin 4.0 mg, Placebo
- Keywords
- Aged, Sleep, Insomnia, Melatonin, Neurobehavioral Manifestations, Circadian Rhythms, Human, Polysomnography, Elderly
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 0.4 mgDrug
Melatonin 4.0 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Melatonin 0.4 mg Receives: Drug: Melatonin 0.4 mg |
| B | Experimental | Melatonin 4.0 mg Receives: Drug: Melatonin 4.0 mg |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Melatonin Level
Pharmacokinetic analysis of maximum melatonin level
Measured: day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalaka Gooneratne
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Nalaka Gooneratne, University of Pennsylvania
- Investigators
- Nalaka S. Gooneratne, MD,MSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230737
- Sponsor's protocol ID
- R01AT001521-01A1
- Other IDs
- R01AT001521-01A1
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2005
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gooneratne NS, Edwards AY, Zhou C, Cuellar N, Grandner MA, Barrett JS. Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults. J Pineal Res. 2012 May;52(4):437-45. doi: 10.1111/j.1600-079X.2011.00958.x. Epub 2012 Feb 21.
PubMed 22348451
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Randomized Trial for Insomnia in the Elderly
- ClinicalTrials.gov ID
- NCT00230737
- Acronym / sponsor ID
- R01AT001521-01A1
- Keywords
- Aged, Sleep, Insomnia, Melatonin, Neurobehavioral Manifestations, Circadian Rhythms, Human, Polysomnography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nalaka GooneratneUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Posted 8 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.
Detailed description
Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. Data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. Generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep.
Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of Week 1 and the end of Week 6. At study entry, participants will be admitted to the General Clinical Research Center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. During Night 1 at the clinic, participants will have urine samples collected throughout the night. Night 2 will be an adaptation night to allow participants to get used to their surroundings. On Night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. Participants with sleep efficiencies of 80% or higher will complete their study participation. Participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. Participants will have study visits at Weeks 1, 3, and 6 to monitor for adverse events. After 6 weeks, participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study. Sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. One month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Melatonin 0.4 mgMelatonin 0.4 mg |
| B | Experimental | Drug: Melatonin 4.0 mgMelatonin 4.0 mg |
| C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- History of insomnia
- Low melatonin levels at study entry
Key exclusion criteria (8 listed)
- History of sleep apnea (temporary cessation of breathing during sleep)
- Diagnosis of restless legs syndrome
- Current alcohol or substance abuse
- Dementia
- Anemia
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 |
|---|---|---|
| Melatonin 0.4 mg | Drug | A |
| Melatonin 4.0 mg | Drug | B |
| Placebo | Drug | C |
Primary outcome
Peak Melatonin Level
Time frame: day 42
Pharmacokinetic analysis of maximum melatonin level
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22348451Gooneratne NS, Edwards AY, Zhou C, Cuellar N, Grandner MA, Barrett JS. Melatonin pharmacokinetics following two different oral surge-sustained release doses in older adults. J Pineal Res. 2012 May;52(4):437-45. doi: 10.1111/j.1600-079X.2011.00958.x. Epub 2012 Feb 21.
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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.
Nalaka S. Gooneratne, MD,MSc principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 0.4 mg and Melatonin 4.0 mg in people with Sleep Initiation and Maintenance Disorders, run by Nalaka Gooneratne 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 8 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 8 Mar 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Melatonin Level (time frame: day 42). 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 NCT00230737, which also lists 1 linked publication.
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 8 Mar 2017.