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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01048242
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 3
Start date July 2006
Completion date March 2009
View Details
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