Trial Outcomes & Findings for The Impact of Arousal Threshold in Obstructive Sleep Apnea (NCT NCT02264353)
NCT ID: NCT02264353
Last Updated: 2019-08-08
Results Overview
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value indicates more severe sleep apnea
COMPLETED
PHASE4
44 participants
14 days (during overnight sleep study after donepezil or placebo is given)
2019-08-08
Participant Flow
Participant milestones
| Measure |
Donepezil Then Placebo
Sleep data with Donepezil given during Visit 1 followed by a 14 day washout period followed by Sleep data with Placebo given during Visit 2
Donepezil: Donepezil 10mg before sleep
|
Placebo Then Donepezil
Sleep data with Placebo given during Visit 1 followed by a 14 day washout period followed by Sleep data with Donepezil given during Visit 2
placebo: One piece of placebo before sleep
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
24
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
All Study Participants
n=41 Participants
Participants who were randomized to receive either Donepezil 10mg tablet or Placebo tablet (matching Donepezil 10mg) before sleep
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
|
Apnea Hypopnea Index (AHI)>5 events/hr; lowest Oxygen Saturation (SaO2)>70%
|
41 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 days (during overnight sleep study after donepezil or placebo is given)The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value indicates more severe sleep apnea
Outcome measures
| Measure |
Donepezil
n=41 Participants
Sleep data with Donepezil given
Donepezil: Donepezil 10mg before sleep
|
Placebo
n=41 Participants
Sleep data with Placebo given
placebo: One piece of placebo before sleep
|
|---|---|---|
|
Apnea Hypopnea Index (AHI)
|
50.0 events/hour
Standard Deviation 23.4
|
51.8 events/hour
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 14 days (during overnight sleep study after donepezil or placebo is given)Arousal Threshold was measured as the average nadir epiglottic airway pressure immediately before electroencephalogram (EEG) arousal. It was measured with an epiglottic pressure catheter. The epiglottic catheter/balloon is linked in a pressure catheter inserted through the de-congested, anesthetized nostril and the tip of the catheter located at hypopharyngeal area.
Outcome measures
| Measure |
Donepezil
n=21 Participants
Sleep data with Donepezil given
Donepezil: Donepezil 10mg before sleep
|
Placebo
n=21 Participants
Sleep data with Placebo given
placebo: One piece of placebo before sleep
|
|---|---|---|
|
Respiratory Arousal Threshold
|
-18.0 cm H20
Interval -27.0 to -11.8
|
-18.9 cm H20
Interval -27.5 to -12.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days (during overnight sleep study after donepezil or placebo is given)The sensitivity of the ventilatory control system (loop gain) was quantified by fitting a simplified mathematical model to the spontaneous ventilatory pattern of obstructive sleep apnea (OSA). The sensitivity of the ventilatory control system (loop gain) was quantified by fitting a simplified mathematical model to the spontaneous ventilatory pattern of OSA 21. Loop gain is reflected in the size of the ventilatory overshoot following a ventilatory perturbation (hypopnea/apnea), where loop gain = response/disturbance. Ventilatory fluctuations are estimated using the square-root transformed nasal pressure waveform. Loop gain was reported as the ventilatory response to a 1 cycle/min disturbance (LG1); a value of LGn\>1 yields periodic central apnea. Calculations were performed using MATLAB
Outcome measures
| Measure |
Donepezil
n=41 Participants
Sleep data with Donepezil given
Donepezil: Donepezil 10mg before sleep
|
Placebo
n=41 Participants
Sleep data with Placebo given
placebo: One piece of placebo before sleep
|
|---|---|---|
|
Loop Gain
|
0.55 Unitless
Standard Deviation 0.15
|
0.58 Unitless
Standard Deviation 0.16
|
Adverse Events
Donepezil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Donepezil
n=41 participants at risk
Sleep data with Donepezil given
Donepezil: Donepezil 10mg before sleep
|
Placebo
n=41 participants at risk
Sleep data with Placebo given
placebo: One piece of placebo before sleep
|
|---|---|---|
|
Investigations
Heart Burn
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Difficulty Falling Asleep
|
0.00%
0/41
|
2.4%
1/41 • Number of events 1
|
Additional Information
Atul Malhotra, MD
University of California, San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place