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

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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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

27 participants in 2 patient groups, including a placebo group

Ramelteon
Experimental group
Description:
Ramelteon 8 mg oral before bedtime
Treatment:
Drug: rozerem
sugar pill
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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