Cluster Headache AttacksNCT01589588
Administration of Oxygen to Cluster Headache Patients
A study testing Open Hudson Mask, Cluster headache mask with 3 L reservoir and Mask 3 in people with Cluster Headache Attacks, run by Mads Barløse at 1 site in Denmark.
Trial summary
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache Attacks
- What is being tested?
- Open Hudson Mask, Cluster headache mask with 3 L reservoir and Mask 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- episodic cluster headache
- regular occurance of attacks and cluster for 2 years
- 2-8 attacks / day
- cluster periods of over 14 days
- duration of current cluster period max 14 days
- ability to differentiate between attacks of CH and other forms of headache
Who cannot join
- Changes in prophylactic treatment a week before trial
- pregnancy or breastfeeding women
- serious somatic or psychiatric disease
- COLD
- chronic or primary or secondary headache > 14 days / month other than CH
- alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.
- Conditions
- Cluster Headache Attacks
- Being tested
- Open Hudson Mask, Cluster headache mask with 3 L reservoir, Mask 3, Carnét oxygen demand valve
- Keywords
- acute treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Hudson MaskDevice
Mask type 1 oxygen
Cluster headache mask with 3 L reservoirDevice
Mask type 2 with oxygen
Mask 3Device
Mask type 3 oxygen
Carnét oxygen demand valveDevice
mask type 3 oxygen
Carnét oxygen demand valveDevice
mask type 3 placebo
| Study group | Role | What they receive |
|---|---|---|
| Mask 1 | Experimental | Not described Receives: Device: Open Hudson Mask |
| Mask 2 | Experimental | Not described Receives: Device: Cluster headache mask with 3 L reservoir |
| Mask 3 | Experimental | Not described Receives: Device: Mask 3; Device: Carnét oxygen demand valve |
| Mask 3, placebo | Placebo comparator | Not described Receives: Device: Carnét oxygen demand valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Pain relief after 15 minutes of treatment
Measured: 15 minutes
Secondary outcomes (1)
Mask preference
subject mask preference
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster Headache AttacksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mads Barløse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mads Barløse, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589588
- Sponsor's protocol ID
- H-2-2011-163
- Status last verified
- Oct 2015
- First submitted
- 26 Apr 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Oxygen to Cluster Headache Patients
- ClinicalTrials.gov ID
- NCT01589588
- Acronym / sponsor ID
- H-2-2011-163
- Conditions
- Cluster Headache Attacks
- Keywords
- acute treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mads BarløseUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mask 1 | Experimental | Device: Open Hudson Mask |
| Mask 2 | Experimental | Device: Cluster headache mask with 3 L reservoir |
| Mask 3 | Experimental | Device: Mask 3, Device: Carnét oxygen demand valve |
| Mask 3, placebo | Placebo comparator | Device: Carnét oxygen demand valve |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- episodic cluster headache
- regular occurance of attacks and cluster for 2 years
- 2-8 attacks / day
- cluster periods of over 14 days
- duration of current cluster period max 14 days
Key exclusion criteria (6 listed)
- Changes in prophylactic treatment a week before trial
- pregnancy or breastfeeding women
- serious somatic or psychiatric disease
- COLD
- chronic or primary or secondary headache > 14 days / month other than CH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Hudson MaskMask type 1 oxygen | Device | Mask 1 |
| Cluster headache mask with 3 L reservoirMask type 2 with oxygen | Device | Mask 2 |
| Mask 3Mask type 3 oxygen | Device | Mask 3 |
| Carnét oxygen demand valvemask type 3 oxygen | Device | Mask 3 |
| Carnét oxygen demand valvemask type 3 placebo | Device | Mask 3, placebo |
Primary outcome
Efficacy
Time frame: 15 minutes
Pain relief after 15 minutes of treatment
1 secondary outcome
Mask preference
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
Related trials for Cluster Headache Attacks
RecruitingObservational study
Italian Trigeminal Autonomic Cephalalgias Assessment Study
Trigeminal Autonomic Cephalalgias, Cluster Headache
Not yet recruitingPhase 2
Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks
Chronic Cluster Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Hudson Mask, Cluster headache mask with 3 L reservoir and Mask 3 in people with Cluster Headache Attacks, run by Mads Barløse at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.