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OpenTrials
Completed

NCT Number: NCT01589588

Administration of Oxygen to Cluster Headache Patients

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

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Key information

Conditions

Cluster Headache Attacks

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Hudson Mask

Device

Mask type 1 oxygen

Cluster headache mask with 3 L reservoir

Device

Mask type 2 with oxygen

Mask 3

Device

Mask type 3 oxygen

Carnét oxygen demand valve

Device

mask type 3 oxygen

Primary outcomes

  1. Efficacy

    Time frame: 15 minutes

    Pain relief after 15 minutes of treatment

Secondary outcomes

  1. Mask preference

    Time frame: 2 days

    subject mask preference

Sponsors and collaborators

Lead sponsor

Mads Barløse

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 2, 2012
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.