Phase 3
Completed N=27
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
Source: ClinicalTrials.gov NCT01048242 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Sleep Onset Latency — 9.7; 34.4 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency |
9.7; 34.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT01048242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.