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

2014-07-23 21:11:08 | BioPortfolio

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.

Description

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Insomnia

Intervention

rozerem, Placebo

Location

University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Completed

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:08-0400

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