Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Arousal threshold, Sedative medication, upper airway
Brief summary
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).
Detailed description
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.
Interventions
DRUGEszopiclone
3mg tablet once prior to sleep
DRUGPlacebo
1 placebo capsule prior to sleep
Sponsors
Sumitomo Pharma America, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 18-64 years old * Untreated obstructive sleep apnea
Exclusion criteria
* Nadir SaO2 \<70% on a baseline PSG * Medications known to affect either sleep, breathing or muscle activity * Major co-morbidities apart from sleep apnea * Allergy to lidocaine, oxymetazoline HCl, or eszopiclone * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 8 hour In-Laboratory Polysomnogram (PSG) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arousal Threshold | 8 hour In-Laboratory Polysomnogram (PSG) | quantified using an epiglottic pressure transducer in CmH2O |
| Nadir Overnight Oxygen Saturation | 8 hour In-Laboratory Polysomnogram (PSG) | Nadir overnight oxygen saturation (%) |
| Sleep Duration | 8 hour In-Laboratory Polysomnogram (PSG) | total sleep duration |
Countries
United States
Participant flow
Recruitment details
subjects recruited 2008-2010 from clinics and ads
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants all study participants who received all interventions | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Apnea Hypopnea Index | 24 events per hour of sleep | Standard Error 4 |
| Sugar Pill | Apnea Hypopnea Index | 31 events per hour of sleep | Standard Error 5 |
Secondary
Arousal Threshold
quantified using an epiglottic pressure transducer in CmH2O
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eszopiclone | Arousal Threshold | -18 cmH2O |
| Sugar Pill | Arousal Threshold | -14 cmH2O |
Secondary
Nadir Overnight Oxygen Saturation
Nadir overnight oxygen saturation (%)
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Nadir Overnight Oxygen Saturation | 80 % oxygen saturation | Standard Error 1 |
| Sugar Pill | Nadir Overnight Oxygen Saturation | 80 % oxygen saturation | Standard Error 1 |
Secondary
Sleep Duration
total sleep duration
Time frame: 8 hour In-Laboratory Polysomnogram (PSG)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eszopiclone | Sleep Duration | 6.8 hours of sleep | Standard Error 0.2 |
| Sugar Pill | Sleep Duration | 5.4 hours of sleep | Standard Error 0.4 |