Administration of Oxygen to Cluster Headache Patients

NCT ID: NCT01589588

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Cluster Headache Attacks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mask 1

Group Type EXPERIMENTAL

Open Hudson Mask

Intervention Type DEVICE

Mask type 1 oxygen

Mask 2

Group Type EXPERIMENTAL

Cluster headache mask with 3 L reservoir

Intervention Type DEVICE

Mask type 2 with oxygen

Mask 3

Group Type EXPERIMENTAL

Mask 3

Intervention Type DEVICE

Mask type 3 oxygen

Carnét oxygen demand valve

Intervention Type DEVICE

mask type 3 oxygen

Mask 3, placebo

Group Type PLACEBO_COMPARATOR

Carnét oxygen demand valve

Intervention Type DEVICE

mask type 3 placebo

Interventions

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Open Hudson Mask

Mask type 1 oxygen

Intervention Type DEVICE

Cluster headache mask with 3 L reservoir

Mask type 2 with oxygen

Intervention Type DEVICE

Mask 3

Mask type 3 oxygen

Intervention Type DEVICE

Carnét oxygen demand valve

mask type 3 oxygen

Intervention Type DEVICE

Carnét oxygen demand valve

mask type 3 placebo

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mads Barløse

OTHER

Sponsor Role lead

Responsible Party

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Mads Barløse

MD, principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2011-163

Identifier Type: -

Identifier Source: org_study_id

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