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

NCT01048242 | Completed Phase 3 Results DMC

• 1 other identifier: 804640
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Sleep Onset Latency

  Time to sleep onset as determined by polysomnography

  4 weeks

Study Arms (2)

Ramelteon

EXPERIMENTAL

Ramelteon 8 mg oral before bedtime

Drug: rozerem

sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

rozerem DRUG

Ramelteon (rozerem) 8mg oral before bedtime

Also known as: Ramelteon

Ramelteon

Placebo DRUG

placebo

sugar pill

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstructive sleep apnea
• Insomnia
• Age\>60

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Takeda: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Apnea, Obstructive

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

Auto-Continuous Positive Airway Pressure units used. Single-night of polysomnography Unequal sized arms despite randomization Low rate of completion of at-home sleep diaries Small sample size (pilot study)

Results Point of Contact

• Title: Nalaka Gooneratne
• Organization: University of Pennsylvania

ngoonera@mail.med.upenn.edu

215 349 5938

Study Officials

• Nalaka Gooneratne, MD, MSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: January 13, 2010
• Study Start: July 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 25, 2023
• Results First Posted: May 3, 2017

Record last verified: 2023-05

Locations

US (1)