Trial Outcomes & Findings for Determinants of Age Related Breathing Instability During Non-Rapid-Eye-Movement (NREM) Sleep (NCT NCT00732199)
NCT ID: NCT00732199
Last Updated: 2017-06-28
Results Overview
The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
4-6 wks for each participant
Results posted on
2017-06-28
Participant Flow
Participants were recruited by posting fliers at the sites approved by the Detroit VA clinical investigations committee and Wayne State IRB (institution review board). They completed a phone interview. If they qualified based on the inclusion/exclusion criteria they completed an informed consent. Dates 2008 to 2014.
Participant milestones
| Measure |
Arm 1
Young adults, age 18-59yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation
|
Arm 2
Older adults, age \>/=60 yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
42
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
34
|
26
|
Reasons for withdrawal
| Measure |
Arm 1
Young adults, age 18-59yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation
|
Arm 2
Older adults, age \>/=60 yrs
hyperventilation and episodic hypoxia: a) noninvasive hyperventilation to determine apneic threshold; b) episodic hypoxia to determine ventilatory long term facilitation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
18
|
|
Overall Study
sleep apnea, inadequate signals/sleep
|
9
|
8
|
Baseline Characteristics
Participants with data available were included in the analysis
Baseline characteristics by cohort
| Measure |
Health Young Adults
n=15 Participants
Health Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Healthy Older Adults
n=19 Participants
Healthy Older adults, age \>55-60yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.9 • n=15 Participants
|
66.9 years
STANDARD_DEVIATION 5.4 • n=19 Participants
|
48.3 years
STANDARD_DEVIATION 17.6 • n=34 Participants
|
|
Sex/Gender, Customized
Apneic Threshold & CO2 Reserve Analysis Population · Female
|
8 Participants
n=15 Participants • Participants with data available were included in the analysis
|
6 Participants
n=10 Participants • Participants with data available were included in the analysis
|
14 Participants
n=25 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
Apneic Threshold & CO2 Reserve Analysis Population · Male
|
7 Participants
n=15 Participants • Participants with data available were included in the analysis
|
4 Participants
n=10 Participants • Participants with data available were included in the analysis
|
11 Participants
n=25 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
LTF and Minute Ventilation Analysis Population · Female
|
NA Participants
n=15 Participants • Participants with data available were included in the analysis
|
8 Participants
n=14 Participants • Participants with data available were included in the analysis
|
NA Participants
n=29 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
LTF and Minute Ventilation Analysis Population · Male
|
NA Participants
n=15 Participants • Participants with data available were included in the analysis
|
6 Participants
n=14 Participants • Participants with data available were included in the analysis
|
NA Participants
n=29 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
Hypoxic Ventilatory Response Analysis Population · Female
|
6 Participants
n=10 Participants • Participants with data available were included in the analysis
|
7 Participants
n=13 Participants • Participants with data available were included in the analysis
|
13 Participants
n=23 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
Hypoxic Ventilatory Response Analysis Population · Male
|
4 Participants
n=10 Participants • Participants with data available were included in the analysis
|
6 Participants
n=13 Participants • Participants with data available were included in the analysis
|
10 Participants
n=23 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
Brief Hyperoxia Response Analysis Population · Female
|
3 Participants
n=9 Participants • Participants with data available were included in the analysis
|
6 Participants
n=10 Participants • Participants with data available were included in the analysis
|
9 Participants
n=19 Participants • Participants with data available were included in the analysis
|
|
Sex/Gender, Customized
Brief Hyperoxia Response Analysis Population · Male
|
6 Participants
n=9 Participants • Participants with data available were included in the analysis
|
4 Participants
n=10 Participants • Participants with data available were included in the analysis
|
10 Participants
n=19 Participants • Participants with data available were included in the analysis
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
12 Participants
n=19 Participants
|
20 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
7 Participants
n=19 Participants
|
14 Participants
n=34 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
19 participants
n=19 Participants
|
34 participants
n=34 Participants
|
|
Body mass index
|
26.4 kg/m2
STANDARD_DEVIATION 2.4 • n=15 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 3.2 • n=19 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 3.6 • n=34 Participants
|
PRIMARY outcome
Timeframe: 4-6 wks for each participantPopulation: Older adults : n=10, 6 females/4 males Young n=15, 8 females/ 7 males; participants with data available were included in the analysis
The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.
Outcome measures
| Measure |
Healthy Young Adults
n=15 Participants
Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Healthy Old Adults
n=10 Participants
Older adults, age \>60 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
|---|---|---|
|
Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve
Carbox-dioxide reserve
|
-4.1 mm Hg
Standard Error 0.4
|
-2.6 mm Hg
Standard Error 0.4
|
|
Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve
Apneic Threshold
|
39.8 mm Hg
Standard Error 0.9
|
36.7 mm Hg
Standard Error 1.3
|
PRIMARY outcome
Timeframe: 4-6 wks for each participantPopulation: Older adults 8 women/6 men;participants with data available were included in the analysis
Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.
Outcome measures
| Measure |
Healthy Young Adults
n=14 Participants
Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Healthy Old Adults
Older adults, age \>60 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
|---|---|---|
|
Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only
|
94.4 percentage of control minute ventilation
Standard Error 3.5
|
—
|
SECONDARY outcome
Timeframe: 4-6 wks for each participantPopulation: older adults: 7 women/6 men; young adults: 6 women/4 men;participants with data available were included in the analysis
Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.
Outcome measures
| Measure |
Healthy Young Adults
n=13 Participants
Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Healthy Old Adults
n=10 Participants
Older adults, age \>60 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
|---|---|---|
|
Hypoxic Ventilatory Response
|
0.21 Liter/minute/%saturation
Standard Error 0.05
|
0.53 Liter/minute/%saturation
Standard Error 0.36
|
SECONDARY outcome
Timeframe: 4-6 wks for each participantPopulation: young adults: 3 women/6 men; older adults: 6 women/4 men; participants with data available were included in the analysis
Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.
Outcome measures
| Measure |
Healthy Young Adults
n=9 Participants
Young adults, age 18-50 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
Healthy Old Adults
n=10 Participants
Older adults, age \>60 yrs
hyperventilation and episodic hypoxia: noninvasive hyperventilation to determine apneic threshold; episodic hypoxia to determine long term facilitation
|
|---|---|---|
|
Brief Hyperoxia Response
|
89.7 percentage of eupneic minute ventilaion
Standard Error 8.4
|
79.6 percentage of eupneic minute ventilaion
Standard Error 9.6
|
Adverse Events
Healthy Young Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Older Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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