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Effects of Melatonin on Insomnia Symptoms in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230737
Recruitment Status : Completed
First Posted : October 3, 2005
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania

Brief Summary:
This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: Melatonin 0.4 mg Drug: Melatonin 4.0 mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin Randomized Trial for Insomnia in the Elderly
Study Start Date : October 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: A
Melatonin 0.4 mg
Drug: Melatonin 0.4 mg
Experimental: B
Melatonin 4.0 mg
Drug: Melatonin 4.0 mg
Placebo Comparator: C Drug: Placebo

Primary Outcome Measures :
  1. Peak Melatonin Level [ Time Frame: day 42 ]
    Pharmacokinetic analysis of maximum melatonin level

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • History of insomnia
  • Low melatonin levels at study entry

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230737

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Nalaka Gooneratne
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Nalaka S. Gooneratne, MD,MSc University of Pennsylvania
Publications of Results:
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Responsible Party: Nalaka Gooneratne, Associate Professor, University of Pennsylvania Identifier: NCT00230737    
Other Study ID Numbers: R01AT001521-01A1 ( U.S. NIH Grant/Contract )
R01AT001521-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2005    Key Record Dates
Results First Posted: March 8, 2017
Last Update Posted: March 8, 2017
Last Verified: January 2017
Keywords provided by Nalaka Gooneratne, University of Pennsylvania:
Neurobehavioral Manifestations
Circadian Rhythms
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants