Trial Outcomes & Findings for The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome (NCT NCT01102270)
NCT ID: NCT01102270
Last Updated: 2017-04-18
Results Overview
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
COMPLETED
EARLY_PHASE1
17 participants
8 hour In-Laboratory Polysomnogram (PSG)
2017-04-18
Participant Flow
subjects recruited 2008-2010 from clinics and ads
Participant milestones
| Measure |
Eszopiclone First, Then Sugar Pill
Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later
|
Sugar Pill First, Then Eszopiclone
Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 Participants
all study participants who received all interventions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Eszopiclone
n=17 Participants
Eszopiclone : 3mg tablet once prior to sleep
|
Sugar Pill
n=17 Participants
Placebo : 1 placebo capsule prior to sleep
|
|---|---|---|
|
Apnea Hypopnea Index
|
24 events per hour of sleep
Standard Error 4
|
31 events per hour of sleep
Standard Error 5
|
SECONDARY outcome
Timeframe: 8 hour In-Laboratory Polysomnogram (PSG)quantified using an epiglottic pressure transducer in CmH2O
Outcome measures
| Measure |
Eszopiclone
n=17 Participants
Eszopiclone : 3mg tablet once prior to sleep
|
Sugar Pill
n=17 Participants
Placebo : 1 placebo capsule prior to sleep
|
|---|---|---|
|
Arousal Threshold
|
-18 cmH2O
Interval -22.1 to -15.1
|
-14 cmH2O
Interval -19.9 to 10.9
|
SECONDARY outcome
Timeframe: 8 hour In-Laboratory Polysomnogram (PSG)Nadir overnight oxygen saturation (%)
Outcome measures
| Measure |
Eszopiclone
n=17 Participants
Eszopiclone : 3mg tablet once prior to sleep
|
Sugar Pill
n=17 Participants
Placebo : 1 placebo capsule prior to sleep
|
|---|---|---|
|
Nadir Overnight Oxygen Saturation
|
80 % oxygen saturation
Standard Error 1
|
80 % oxygen saturation
Standard Error 1
|
SECONDARY outcome
Timeframe: 8 hour In-Laboratory Polysomnogram (PSG)total sleep duration
Outcome measures
| Measure |
Eszopiclone
n=17 Participants
Eszopiclone : 3mg tablet once prior to sleep
|
Sugar Pill
n=17 Participants
Placebo : 1 placebo capsule prior to sleep
|
|---|---|---|
|
Sleep Duration
|
6.8 hours of sleep
Standard Error 0.2
|
5.4 hours of sleep
Standard Error 0.4
|
Adverse Events
Eszopiclone
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place