Administration of Oxygen to Cluster Headache Patients | NCT01589588

Studies
Administration of Oxygen to Cluster Headache Patients

NCT01589588

Sponsor

Mads Barløse

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

57Actual

Phase

Not Applicable

Conditions

Cluster Headache Attacks

Interventions

Open Hudson Mask
Cluster headache mask with 3 L reservoir
Mask 3
Carnét oxygen demand valve
Carnét oxygen demand valve

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 26, 2012

First Submission Date that Met QC Criteria

Apr 30, 2012

First Posted Date

May 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Description Module

Brief Summary

This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open Hudson Mask	Device	Mask type 1 oxygen	Mask 1
Cluster headache mask with 3 L reservoir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy	Pain relief after 15 minutes of treatment	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Mask preference	subject mask preference	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center		Glostrup Municipality		2600	Denmark