Trial Outcomes & Findings for Sleep and Breathing in the General Population - Chemical Stimuli (NCT NCT04720547)
NCT ID: NCT04720547
Last Updated: 2023-12-06
Results Overview
The number of central apneas and hypopneas per hour of sleep was obtained from polysomnography studies.
COMPLETED
PHASE4
14 participants
one night
2023-12-06
Participant Flow
Participant milestones
| Measure |
Experimental: Zolpidem, Then No Treatment
Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.
Zolpidem: A nonbenzodiazepine hypnotic
|
Experimental: No Treatment, Then Zolpidem
Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep and Breathing in the General Population - Chemical Stimuli
Baseline characteristics by cohort
| Measure |
Zolpidem, Then No Treatment
n=6 Participants
Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.
Zolpidem: A nonbenzodiazepine hypnotic
No Treatment: The Control condition in which participants do not receive medication.
|
No Treatment, Then Zolpidem
n=5 Participants
Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.
Zolpidem: A nonbenzodiazepine hypnotic
No Treatment: The Control condition in which participants do not receive medication.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Veteran Status: Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
BMI
|
29.6 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Neck Girth
|
38.9 cm
STANDARD_DEVIATION 6.2 • n=5 Participants
|
41.4 cm
STANDARD_DEVIATION 3.5 • n=7 Participants
|
40.0 cm
STANDARD_DEVIATION 5.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: one nightThe number of central apneas and hypopneas per hour of sleep was obtained from polysomnography studies.
Outcome measures
| Measure |
Zolpidem
n=10 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=10 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
The Central Apnea-hypopnea Index
|
14.1 events per hour
Standard Error 4.4
|
29.9 events per hour
Standard Error 7.6
|
PRIMARY outcome
Timeframe: one nightA measure of the frequency of respiratory-related arousals during sleep
Outcome measures
| Measure |
Zolpidem
n=10 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=10 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
Respiratory Arousal Index
|
23.3 events per hour
Standard Error 4.4
|
39.7 events per hour
Standard Error 7.7
|
SECONDARY outcome
Timeframe: one nightCO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative. CO2 reserve is defined as the difference between the eupneic end-tidal CO2 pressure and the end-tidal CO2 pressure induced by the ventilation protocol that is sufficient to trigger a central apnea as defined by the American Academy of Sleep Medicine.
Outcome measures
| Measure |
Zolpidem
n=8 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=8 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
CO2 Reserve
|
-0.63 mmHg
Standard Error 2.42
|
-0.44 mmHg
Standard Error 4.17
|
SECONDARY outcome
Timeframe: one nightController gain is a ventilatory response to changes in end-tidal PCO2. Controller gain was calculated by dividing the difference in minute ventilation between the post-mechanical ventilation induced by the ventilation protocol and steady-state respiration by the difference in the end-tidal CO2 pressure between the mechanical ventilation and steady-state respiration.
Outcome measures
| Measure |
Zolpidem
n=5 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=5 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
Controller Gain
|
2.39 L/min*mmHg
Standard Error 1.10
|
3.95 L/min*mmHg
Standard Error 2.34
|
SECONDARY outcome
Timeframe: one nightPlant gain is a blood gas response to a change in ventilation. This measure represents the effectiveness of the "plant" in eliminating CO2. Steady-state plant gain was calculated from the ratio of end-tidal CO2 to minute ventilation during stable respiration.
Outcome measures
| Measure |
Zolpidem
n=8 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=8 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
Stead-State Plant Gain (mmHg
|
4.78 mmHg*L/min
Standard Error 0.79
|
5.27 mmHg*L/min
Standard Error 1.0
|
SECONDARY outcome
Timeframe: one nightThe nadir pressure in the upper airway (supra-glottic pressure) prior to the occurrence of an arousal
Outcome measures
| Measure |
Zolpidem
n=4 Participants
Outcomes from the Zolpidem night for participants in both sequences
|
No Treatment
n=4 Participants
Outcomes from the No Treatment night for participants in both sequences
|
|---|---|---|
|
Respiratory Arousal Threshold
|
-8.72 cmH2O
Standard Error 4.20
|
-8.25 cmH2O
Standard Error 5.63
|
Adverse Events
Zolpidem
No Treatment
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