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

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea; Insomnia
• Interventions: Drug: rozerem; Drug: Placebo

• Registration Number: NCT01048242
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-13
• Results First Submitted: 2017-03-22
• Results First Submitted QC: 2017-03-22
• Results First Posted: 2017-05-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramelteon	rozerem	Ramelteon 8 mg oral before bedtime
sugar pill	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sleep Onset Latency	4 weeks	Time to sleep onset as determined by polysomnography

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States