Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Takeda | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramelteon | Experimental | Ramelteon 8 mg oral before bedtime |
|
| sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rozerem | Drug | Ramelteon (rozerem) 8mg oral before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency | Time to sleep onset as determined by polysomnography | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nalaka Gooneratne, MD, MSc | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ramelteon | Ramelteon 8 mg oral before bedtime |
| FG001 | Sugar Pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ramelteon | Ramelteon 8 mg oral before bedtime |
| BG001 | Sugar Pill | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Onset Latency | Time to sleep onset as determined by polysomnography | analysis per protocol | Posted | Jun 2010 | Mean | Standard Deviation | minutes | 4 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramelteon | Ramelteon 8 mg oral before bedtime |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin ulcer--unrelated to study drug treatment, not serious |
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)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nalaka Gooneratne | University of Pennsylvania | 215 349 5938 | ngoonera@mail.med.upenn.edu |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C495910 | ramelteon |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | placebo |
|
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Sugar Pill | 0 | 13 | 2 | 13 |
|
| Paranasal sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Sinusitis--unrelated to study drug treatment, not serious |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea--unrelated to study drug treatment, not serious |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Musculoskeletal fracture after being hit by a bicyclist----unrelated to study drug treatment, not serious |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Abdominal pain--unrelated to study drug treatment, not serious |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea--unrelated to study drug treatment, not serious |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |