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OpenTrials
Completed

NCT Number: NCT01048242

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

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.

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Key information

Conditions

Insomnia Apnea Dyssomnias Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rozerem

Drug

Ramelteon (rozerem) 8mg oral before bedtime

Other names: Ramelteon

Placebo

Drug

placebo

Primary outcomes

  1. Sleep Onset Latency

    Time frame: 4 weeks

    Time to sleep onset as determined by polysomnography

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2010
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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