NCT03397563

Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache

Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache - a Randomized Controlled Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cluster headache is also called suicide headache due to excruciating nocturnal attacks. There are few treatment options available. Inhalation of oxygen has shown to abort the attacks. Continuous positive airway pressure (CPAP) is a machine used during sleep to treat respiratory failure. Automatic CPAP machines adjust the air pressure through the night to keep the upper airways patent. Single reports have shown a high prevalence of obstructive sleep apnea in people suffering from cluster headache, and positive effects of CPAP treatment, but no randomized controlled trial has been conducted so far. If proven effective CPAP would make an affordable treatment option for many patients within the existing healthcare system.

Detailed description

This is a single center study carried out in collaboration between the neurological, neurophysiological and thoracic departments at St. Olavs Hospital in Trondheim. Participants will keep sleep and headache diaries in a baseline period of 4 weeks, then receive treatment (CPAP or sham-CPAP at nighttime) during 8 weeks, have a 4 week wash out period followed by a second treatment period of 8 weeks (CPAP or sham-CPAP). Finally there will be follow-up during 1 month. Throughout the whole study (7 months) participants keep a headache diary. Participants must maintain current preventive and sleep medication regimens during the whole study period, and may use acute medication of choice (sumatriptan, oxygen or other). Sleep registration in all participants will be done by polysomnography(PSG). An Ultra Wide Band radar/movement sensor device will be used to detect sleep patterns, together with wrist pulse oximetry and wrist actigraphy during PSG and the last week of each treatment period. Neurophysiologic tests such as temperature and pressure thresholds will be measured before PSG and after each treatment period.

Conditions

• Cluster Headache
• Chronic Disease

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure	standard automatic CPAP machine set on optimal automatic pressure
DEVICE	sham Continuous Positive Airway Pressure	CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask

Timeline

• Start date: 2018-01-16
• Primary completion: 2019-08-21
• Completion: 2019-08-21
• First posted: 2018-01-12
• Last updated: 2020-03-31

Locations

1 site across 1 country: Norway