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Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

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ClinicalTrials.gov Identifier: NCT01048242
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : May 3, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Condition or disease Intervention/treatment Phase
Insomnia Obstructive Sleep Apnea Drug: rozerem Drug: Placebo Phase 3

Detailed Description:
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

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: Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Study Start Date : July 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Ramelteon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ramelteon
Ramelteon 8 mg oral before bedtime
Drug: rozerem
Ramelteon (rozerem) 8mg oral before bedtime
Other Name: Ramelteon
Placebo Comparator: sugar pill Drug: Placebo

Primary Outcome Measures :
  1. Sleep Onset Latency [ Time Frame: 4 weeks ]
    Time to sleep onset as determined by polysomnography

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obstructive sleep apnea
  • Insomnia
  • Age>60

Exclusion Criteria:

  • Cognitive impairment
  • Active alcohol or substance abuse
  • Active use of other sedative-hypnotic agents
  • Active use of fluvoxamine (drug interaction with Ramelteon
  • Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel
  • Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome
  • Severe Chronic Obstructive Pulmonary Disease

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 ClinicalTrials.gov identifier (NCT number): NCT01048242

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Nalaka Gooneratne, MD, MSc University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01048242     History of Changes
Other Study ID Numbers: 804640
First Posted: January 13, 2010    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders