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

Primary Purpose

Insomnia, Obstructive Sleep Apnea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rozerem
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramelteon

sugar pill

Arm Description

Ramelteon 8 mg oral before bedtime

Outcomes

Primary Outcome Measures

Sleep Onset Latency
Time to sleep onset as determined by polysomnography

Secondary Outcome Measures

Full Information

First Posted
April 15, 2009
Last Updated
May 23, 2023
Sponsor
University of Pennsylvania
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01048242
Brief Title
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Official Title
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramelteon
Arm Type
Experimental
Arm Description
Ramelteon 8 mg oral before bedtime
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rozerem
Other Intervention Name(s)
Ramelteon
Intervention Description
Ramelteon (rozerem) 8mg oral before bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Sleep Onset Latency
Description
Time to sleep onset as determined by polysomnography
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 Chronic Obstructive Pulmonary Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalaka Gooneratne, MD, MSc
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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