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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Cluster Headache
• Intervention / Treatment: Device: Continuous Positive Airway Pressure; Device: sham Continuous Positive Airway Pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP treatment; Continuous Positive Airway Pressure (CPAP)	Device: Continuous Positive Airway Pressure; standard automatic CPAP machine set on optimal automatic pressure; Other Names: CPAP; 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; Other Names: sham-CPAP
Sham Comparator: Sham-CPAP treatment; sham Continuous Positive Airway Pressure (sham-CPAP)	Device: Continuous Positive Airway Pressure; standard automatic CPAP machine set on optimal automatic pressure; Other Names: CPAP; 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; Other Names: sham-CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in number of cluster headache attacks per week at week 9-12	12 weeks
change from baseline in number of cluster headache attacks per week at week 21-24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the number of nightly cluster attacks per week at week 9-12		12 weeks
Change from baseline in the number of nightly cluster attacks per week at week 21-24		24 weeks
Change from baseline in cluster headache start time per week at week 9-12		12 weeks
Change from baseline in cluster headache start time per week at week 21-24		24 weeks
Change from baseline in the number of days with cluster headache per week at week 9-12		12 weeks
Change from baseline in the number of days with cluster headache per week at week 21-24		24 weeks
Change from baseline in the number of hours with cluster headache per week at week 9-12		12 weeks
Change from baseline in the number of hours with cluster headache per week at week 21-24		24 weeks
Change from baseline in use of acute treatment per week at week 9-12		12 weeks
Change from baseline in use of acute treatment per week at week 21-24		24 weeks
Change from baseline in subjective sleep quality in week 12	according to sleep diary	12 weeks
Change from baseline in subjective sleep quality in week 24	according to sleep diary	24 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12		12 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24		24 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12		12 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24		24 weeks
Change from baseline in heat/cold pain thresholds at week 12 according to thermal test		12 weeks
Change from baseline in pressure pain thresholds at week 12 according to algometry test		12 weeks
Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.		24 weeks
Change from baseline in pressure pain thresholds at week 24 according to algometry test		24 weeks

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Geirmund Unsgård, MD PhD prof, St. Olavs Hospital; Principal Investigator: Erling Tronvik, MD PhD, Norwegian University of Science and Technology; Study Chair: Lars Jacob Stovner, MD prof, Norwegian Advisory Unit on Headaches

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): August 21, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Polysomnography; Sleep Apnea, Obstructive
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Chronic Disease; Headache; Cluster Headache
• Other Study ID Numbers: 2017/1491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No