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

NCT ID: NCT01048242

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-03-31

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.

Conditions

Insomnia; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ramelteon

Ramelteon 8 mg oral before bedtime

Group Type: EXPERIMENTAL

rozerem

Intervention Type: DRUG

Ramelteon (rozerem) 8mg oral before bedtime

sugar pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

rozerem

Ramelteon (rozerem) 8mg oral before bedtime

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Ramelteon

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nalaka Gooneratne, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

804640

Identifier Type: -

Identifier Source: org_study_id