Trial Outcomes & Findings for Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures (NCT NCT01408329)
NCT ID: NCT01408329
Last Updated: 2015-09-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).
Results posted on
2015-09-22
Participant Flow
Recruited from Palo Alto and surrounding areas by flyer and advertisement
Medical Screening Group Matching by 3rd party
Participant milestones
| Measure |
Sham Group
Slowly fluctuating pressures simulating altitude up to 607 meters
|
Cyclic Hypoxic Group
Rapidly fluctuating pressures simulating altitude up to 6096 meters
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures
Baseline characteristics by cohort
| Measure |
Sham Group
n=13 Participants
Slowly fluctuating pressures simulating altitude up to 607 meters
|
Cyclic Hypoxic Group
n=15 Participants
Rapidly fluctuating pressures simulating altitude up to 6096 meters
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 4 • n=99 Participants
|
48 years
STANDARD_DEVIATION 6 • n=107 Participants
|
49 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).Population: Those that completed the study
Outcome measures
| Measure |
Sham Group
n=10 Participants
Slowly fluctuating pressures simulating altitude up to 607 meters
|
Cyclic Hypoxic Group
n=11 Participants
Rapidly fluctuating pressures simulating altitude up to 6097m
|
|---|---|---|
|
Plasma Glucose Concentration
Baseline
|
93.8 mg/dl
Standard Deviation 7.6
|
95.7 mg/dl
Standard Deviation 9.0
|
|
Plasma Glucose Concentration
3 weeks
|
94.1 mg/dl
Standard Deviation 6.2
|
93.3 mg/dl
Standard Deviation 8.5
|
|
Plasma Glucose Concentration
6 weeks
|
95.3 mg/dl
Standard Deviation 7.5
|
92.5 mg/dl
Standard Deviation 4.3
|
|
Plasma Glucose Concentration
10 weeks
|
96.8 mg/dl
Standard Deviation 8.9
|
90.8 mg/dl
Standard Deviation 6.9
|
Adverse Events
Sham Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cyclic Hypoxic Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Group
n=13 participants at risk
Slowly fluctuating simulated altitude up to 607 meters.
|
Cyclic Hypoxic Group
n=15 participants at risk
Rapidly fluctuating simulated altitude up to 6097 meters
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • The events occured over the 1 year period of the study
The events did not require medical attention, but prevented the subjects from advancing to the higher levels of altitude exposure
|
20.0%
3/15 • Number of events 3 • The events occured over the 1 year period of the study
The events did not require medical attention, but prevented the subjects from advancing to the higher levels of altitude exposure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place