Effects of Melatonin on Insomnia Symptoms in Older Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00230737
First received: September 12, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin Randomized Trial for Insomnia in the Elderly

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Sleep efficiency (subjective and objective)
  • neurobehavioral assessment battery

Secondary Outcome Measures:
  • psychomotor vigilance testing
  • functional outcomes of sleepiness questionnaire

Estimated Enrollment: 190
Study Start Date: October 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230737

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Nalaka S. Gooneratne, MD,MSc University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230737     History of Changes
Other Study ID Numbers: R01 AT001521-01A1, R01AT001521-01A1
Study First Received: September 12, 2005
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by University of Pennsylvania:
Aged
Sleep
Insomnia
Melatonin
Neurobehavioral Manifestations
Circadian Rhythms
Human
Polysomnography
Elderly

Additional relevant MeSH terms:
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014