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 Details — Status: Completed

Administrative data

• NCT number: NCT01048242
• Other study ID #: 804640
• Status: Completed
• Phase: Phase 3
• Start date: July 2006
• Est. completion date: March 2009

Study information

• Verified date: May 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Insomnia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• rozerem
Ramelteon (rozerem) 8mg oral before bedtime
• Placebo
placebo

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Onset Latency	Time to sleep onset as determined by polysomnography	4 weeks