Insomnia, Obstructive Sleep Apnea
Conditions
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.
Interventions
DRUGrozerem
Ramelteon (rozerem) 8mg oral before bedtime
DRUGPlacebo
placebo
Sponsors
Takeda
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | 4 weeks | Time to sleep onset as determined by polysomnography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ramelteon Ramelteon 8 mg oral before bedtime | 12 |
| Sugar Pill | 15 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | See study flow chart | 4 | 2 |
Baseline characteristics
| Characteristic | Sugar Pill | Ramelteon | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70.6 years STANDARD_DEVIATION 3.5 | 73.6 years STANDARD_DEVIATION 5.6 | 72 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 15 participants | 12 participants | 27 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 2 / 13 |
| serious Total, serious adverse events | 0 / 8 | 0 / 13 |
Outcome results
Primary
Sleep Onset Latency
Time to sleep onset as determined by polysomnography
Time frame: 4 weeks
Population: analysis per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon | Sleep Onset Latency | 9.7 minutes | Standard Deviation 10.3 |
| Sugar Pill | Sleep Onset Latency | 34.4 minutes | Standard Deviation 30.7 |