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

September 12, 2005
January 12, 2010
October 2004
May 2008   (final data collection date for primary outcome measure)
  • Sleep efficiency (subjective and objective)
  • neurobehavioral assessment battery
Same as current
Complete list of historical versions of study NCT00230737 on ClinicalTrials.gov Archive Site
  • psychomotor vigilance testing
  • functional outcomes of sleepiness questionnaire
Same as current
Not Provided
Not Provided
 
Effects of Melatonin on Insomnia Symptoms in Older Adults
Melatonin Randomized Trial for Insomnia in the Elderly

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: Melatonin 0.4 mg
  • Drug: Melatonin 4.0 mg
  • Drug: Placebo
  • Experimental: A
    Melatonin 0.4 mg
    Intervention: Drug: Melatonin 0.4 mg
  • Experimental: B
    Melatonin 4.0 mg
    Intervention: Drug: Melatonin 4.0 mg
  • Placebo Comparator: C
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230737
R01 AT001521-01A1, R01AT001521-01A1
Yes
Not Provided
University of Pennsylvania
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Nalaka S. Gooneratne, MD,MSc University of Pennsylvania
University of Pennsylvania
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP