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

St. Olavs Hospital

Status: Completed

Conditions: Chronic Disease; Cluster Headache

Treatments: Device: sham Continuous Positive Airway Pressure; Device: Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03397563

2017/1491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfils the diagnostic criteria for chronic cluster headache according to ICHD-3 beta 3.1.2.
• is able to separate cluster headache attacks from other types of headache.
• agrees to maintain current preventive headache and sleep medication regimens (no change in type, frequency, or dose) during the whole study period.
• Signed informed consent.

Exclusion criteria

• disorders with contraindications for use of continuous positive airway pressure (e.g. unable to remove the ventilation mask due to a movement disorders).
• Nightly cluster headache attacks
• Pregnancy or planned pregnancy
• having had a change in type, dosage or dose frequency of preventive headache or sleep medications < 1 months prior to inclusion.
• Severe depression or other psychiatric disorder that may interfere with the treatment.
• Abuse of alcohol or illicit drugs.
• Other severe chronic pain conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

CPAP treatment

Experimental group

Description:

Continuous Positive Airway Pressure (CPAP)

Treatment:

Device: Continuous Positive Airway Pressure

Device: sham Continuous Positive Airway Pressure

Sham-CPAP treatment

Sham Comparator group

Description:

sham Continuous Positive Airway Pressure (sham-CPAP)

Treatment:

Device: Continuous Positive Airway Pressure

Device: sham Continuous Positive Airway Pressure