Trial Outcomes & Findings for Consequences of Nocturnal and Daytime Hypoxemia in COPD (NCT NCT00547456)
NCT ID: NCT00547456
Last Updated: 2015-12-16
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-12-16
Participant Flow
recruitment details occurred as outlined in protocol
Participant milestones
| Measure |
Decrease in Oxygen Level When Sleeping
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Consequences of Nocturnal and Daytime Hypoxemia in COPD
Baseline characteristics by cohort
| Measure |
Decrease in Oxygen Level When Sleeping
n=20 Participants
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Oxygen: Oxygen 2-3L Nasal cannula
|
|---|---|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
nocturnal hypoxemia
|
20 participants
n=5 Participants
|
|
Number of Participants with Nocturnal and Daytime Hypoxemia in COPD
|
20 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.
Outcome measures
Outcome data not reported
Adverse Events
Decrease in Oxygen Level When Sleeping
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