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

University of Pennsylvania

Status and phase

Completed

Phase 3

Conditions

Insomnia

Obstructive Sleep Apnea

Treatments

Drug: Placebo

Drug: rozerem

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01048242

804640

Details and patient eligibility

About

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.

Full description

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

Enrollment

27 patients

Sex

All

Ages

60+ years old

Volunteers

No 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