Clinical trial NCT03397563: Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache
Official title: Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache - a Randomized Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache
Chronic Disease
Keywords: Continuous Positive Airway Pressure
Sleep Apnea, Obstructive
Polysomnography
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2018-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in number of cluster headache attacks per week at week 9-12
timeFrame: 12 weeks
measure: change from baseline in number of cluster headache attacks per week at week 21-24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in the number of nightly cluster attacks per week at week 9-12
timeFrame: 12 weeks
measure: Change from baseline in the number of nightly cluster attacks per week at week 21-24
timeFrame: 24 weeks
measure: Change from baseline in cluster headache start time per week at week 9-12
timeFrame: 12 weeks
measure: Change from baseline in cluster headache start time per week at week 21-24
timeFrame: 24 weeks
measure: Change from baseline in the number of days with cluster headache per week at week 9-12
timeFrame: 12 weeks
measure: Change from baseline in the number of days with cluster headache per week at week 21-24
timeFrame: 24 weeks
measure: Change from baseline in the number of hours with cluster headache per week at week 9-12
timeFrame: 12 weeks
measure: Change from baseline in the number of hours with cluster headache per week at week 21-24
timeFrame: 24 weeks
measure: Change from baseline in use of acute treatment per week at week 9-12
timeFrame: 12 weeks
measure: Change from baseline in use of acute treatment per week at week 21-24
timeFrame: 24 weeks
measure: Change from baseline in subjective sleep quality in week 12
timeFrame: 12 weeks
measure: Change from baseline in subjective sleep quality in week 24
timeFrame: 24 weeks
measure: Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12
timeFrame: 12 weeks
measure: Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24
timeFrame: 24 weeks
measure: Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12
timeFrame: 12 weeks
measure: Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24
timeFrame: 24 weeks
measure: Change from baseline in heat/cold pain thresholds at week 12 according to thermal test
timeFrame: 12 weeks
measure: Change from baseline in pressure pain thresholds at week 12 according to algometry test
timeFrame: 12 weeks
measure: Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.
timeFrame: 24 weeks
measure: Change from baseline in pressure pain thresholds at week 24 according to algometry test
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Geirmund Unsgård, MD PhD prof
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Erling Tronvik, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Advisory Unit on Headaches
name: Lars Jacob Stovner, MD prof
role: STUDY_CHAIR
References: