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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01048242
First received: April 15, 2009
Last updated: January 11, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Enrollment: 29
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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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 COPD
  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: 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

No publications provided

Responsible Party: Nalaka Gooneratne, MD, MSc / Assistant Professor of Medicine, University of Pennsylvania School of Medicine
ClinicalTrials.gov Identifier: NCT01048242     History of Changes
Other Study ID Numbers: 804640
Study First Received: April 15, 2009
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014