- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048242
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
May 23, 2023 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: sugar pill
|
placebo
|
Experimental: Ramelteon
Ramelteon 8 mg oral before bedtime
|
Ramelteon (rozerem) 8mg oral before bedtime
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Onset Latency
Time Frame: 4 weeks
|
Time to sleep onset as determined by polysomnography
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nalaka Gooneratne, MD, MSc, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
April 15, 2009
First Submitted That Met QC Criteria
January 11, 2010
First Posted (Estimated)
January 13, 2010
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 804640
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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