Trial Outcomes & Findings for A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache (NCT NCT01298921)
NCT ID: NCT01298921
Last Updated: 2019-07-11
Results Overview
Headache response after 30 minutes of oxygen treatment. Headache response is defined as a reduction in headache pain intensity from moderate, severe, or very severe pain to mild or no pain.
TERMINATED
PHASE1
4 participants
30 minutes
2019-07-11
Participant Flow
After the enrollment of 4 participants in this study, the PI left Geisinger and the study was terminated. Geisinger does not have any details regarding which Arm/Group participants completed. Therefore, 0 was added as the enrollment for each group.
Participant milestones
| Measure |
Continous Flow Oxygen
Oxygen : 100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
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Oxygen Demand Valve
Oxygen : A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
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|---|---|---|
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Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
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0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 30 minutesPopulation: Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).
Headache response after 30 minutes of oxygen treatment. Headache response is defined as a reduction in headache pain intensity from moderate, severe, or very severe pain to mild or no pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 to 60 minutesPopulation: Data cannot be found despite efforts to contact primary investigator. Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s).
1. Percentage of patients with no pain after 30 minutes of treatment 2. Headache relief and pain free at other time points (5 to 60 minutes) 3. Reduction of autonomic symptoms at 30 minutes 4. Any difference in treatment response between episodic and chronic cluster headache patients (if patient #'s allow) 5. Rescue medication use 6. Cluster headache recurrence by 24 hours post oxygen treatments 7. Patient satisfaction with treatment response compared with prior oxygen treatment if have utilized8.Likelihood of choosing this technique again to treat a cluster headache attack
Outcome measures
Outcome data not reported
Adverse Events
Continous Flow Oxygen
Oxygen Demand Valve
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