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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01048242
First Posted: January 13, 2010
Last Update Posted: June 1, 2017
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.
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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 Intervention Phase
Insomnia Obstructive Sleep Apnea Drug: rozerem Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

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


Enrollment: 27
Study Start Date: July 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

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

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
Criteria

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
  Contacts and Locations
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


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01048242     History of Changes
Other Study ID Numbers: 804640
First Submitted: April 15, 2009
First Posted: January 13, 2010
Results First Submitted: March 22, 2017
Results First Posted: May 3, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Apnea
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
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders