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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01HL095491-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).
Obstructive sleep apnea is an exceedingly common disease with major neurocognitive and cardiovascular consequences. The current primary treatment e.g. Continuous positive airway pressure (CPAP) is effective but poorly tolerated by many patients particularly those with mild-moderate disease. Secondary treatments such as oral appliances to advance the mandible or surgical procedures to enlarge the airway are commonly appealing to the patient. However, these approaches have only modest success in reducing apnea frequency to an acceptable level. Thus, finding tolerable and effective therapy for sleep apnea remains an important objective.
The causes of sleep apnea vary between patients. Targeted therapy according to the underlying causes of sleep apnea in individual patients is likely to be most effective. However, current therapeutic options for sleep apnea are quite limited. The purpose of this physiological research study is to determine if taking eszopiclone (Lunesta)changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (the arousal threshold) and if administration of the sedative medication eszopiclone (Lunesta) to certain sleep apnea patients (those with a low arousal threshold ie wake up easily) would be beneficial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone | Active Comparator | Eszopiclone 3mg prior to sleep (1 night) |
|
| Sugar Pill | Placebo Comparator | Sugar Pill (placebo) prior to sleep (1 night) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | 3mg tablet once prior to sleep |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe | 8 hour In-Laboratory Polysomnogram (PSG) |
| Measure | Description | Time Frame |
|---|---|---|
| Arousal Threshold | quantified using an epiglottic pressure transducer in CmH2O | 8 hour In-Laboratory Polysomnogram (PSG) |
| Nadir Overnight Oxygen Saturation | Nadir overnight oxygen saturation (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Malhotra, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital, Division of Sleep Medicine | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21269278 | Result | Eckert DJ, Owens RL, Kehlmann GB, Wellman A, Rahangdale S, Yim-Yeh S, White DP, Malhotra A. Eszopiclone increases the respiratory arousal threshold and lowers the apnoea/hypopnoea index in obstructive sleep apnoea patients with a low arousal threshold. Clin Sci (Lond). 2011 Jun;120(12):505-14. doi: 10.1042/CS20100588. |
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published
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subjects recruited 2008-2010 from clinics and ads
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone First, Then Sugar Pill | Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later |
| FG001 | Sugar Pill First, Then Eszopiclone | Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
although 28 were screened, only 17 were randomized since 11 did not qualify for the randomization portion of the study
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | all study participants who received all interventions |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Arousal Threshold | quantified using an epiglottic pressure transducer in CmH2O | Posted | Median | Inter-Quartile Range | cmH2O | 8 hour In-Laboratory Polysomnogram (PSG) |
|
|
Overnight study and the following morning
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone | Eszopiclone : 3mg tablet once prior to sleep |
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We excluded patients with blood arterial oxygen saturations <70% as we wanted to avoid any potential risks associated with this group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Atul Malhotra | Brigham and Women's Hospital | 6177326488 | amalhotra1@partners.org |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Placebo | Drug | 1 placebo capsule prior to sleep |
|
|
| 8 hour In-Laboratory Polysomnogram (PSG) |
| Sleep Duration | total sleep duration | 8 hour In-Laboratory Polysomnogram (PSG) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Nadir Overnight Oxygen Saturation | Nadir overnight oxygen saturation (%) | Posted | Mean | Standard Error | % oxygen saturation | 8 hour In-Laboratory Polysomnogram (PSG) |
|
|
|
| Primary | Apnea Hypopnea Index | number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe | Posted | Mean | Standard Error | events per hour of sleep | 8 hour In-Laboratory Polysomnogram (PSG) |
|
|
|
| Secondary | Sleep Duration | total sleep duration | Posted | Mean | Standard Error | hours of sleep | 8 hour In-Laboratory Polysomnogram (PSG) |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Sugar Pill | Placebo : 1 placebo capsule prior to sleep | 0 | 17 | 0 | 17 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011725 |
| Pyridines |
| D002241 | Carbohydrates |