Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache (CPAP)
Primary Purpose
Cluster Headache, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
sham Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache focused on measuring Continuous Positive Airway Pressure, Sleep Apnea, Obstructive, Polysomnography
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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CPAP treatment
Sham-CPAP treatment
Arm Description
Continuous Positive Airway Pressure (CPAP)
sham Continuous Positive Airway Pressure (sham-CPAP)
Outcomes
Primary Outcome Measures
change from baseline in number of cluster headache attacks per week at week 9-12
change from baseline in number of cluster headache attacks per week at week 21-24
Secondary Outcome Measures
Change from baseline in the number of nightly cluster attacks per week at week 9-12
Change from baseline in the number of nightly cluster attacks per week at week 21-24
Change from baseline in cluster headache start time per week at week 9-12
Change from baseline in cluster headache start time per week at week 21-24
Change from baseline in the number of days with cluster headache per week at week 9-12
Change from baseline in the number of days with cluster headache per week at week 21-24
Change from baseline in the number of hours with cluster headache per week at week 9-12
Change from baseline in the number of hours with cluster headache per week at week 21-24
Change from baseline in use of acute treatment per week at week 9-12
Change from baseline in use of acute treatment per week at week 21-24
Change from baseline in subjective sleep quality in week 12
according to sleep diary
Change from baseline in subjective sleep quality in week 24
according to sleep diary
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24
Change from baseline in heat/cold pain thresholds at week 12 according to thermal test
Change from baseline in pressure pain thresholds at week 12 according to algometry test
Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.
Change from baseline in pressure pain thresholds at week 24 according to algometry test
Full Information
NCT ID
NCT03397563
First Posted
January 4, 2018
Last Updated
March 30, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03397563
Brief Title
Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache
Acronym
CPAP
Official Title
Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache - a Randomized Controlled Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache, Chronic Disease
Keywords
Continuous Positive Airway Pressure, Sleep Apnea, Obstructive, Polysomnography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
Continuous Positive Airway Pressure (CPAP)
Arm Title
Sham-CPAP treatment
Arm Type
Sham Comparator
Arm Description
sham Continuous Positive Airway Pressure (sham-CPAP)
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Other Intervention Name(s)
CPAP
Intervention Description
standard automatic CPAP machine set on optimal automatic pressure
Intervention Type
Device
Intervention Name(s)
sham Continuous Positive Airway Pressure
Other Intervention Name(s)
sham-CPAP
Intervention Description
CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask
Primary Outcome Measure Information:
Title
change from baseline in number of cluster headache attacks per week at week 9-12
Time Frame
12 weeks
Title
change from baseline in number of cluster headache attacks per week at week 21-24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the number of nightly cluster attacks per week at week 9-12
Time Frame
12 weeks
Title
Change from baseline in the number of nightly cluster attacks per week at week 21-24
Time Frame
24 weeks
Title
Change from baseline in cluster headache start time per week at week 9-12
Time Frame
12 weeks
Title
Change from baseline in cluster headache start time per week at week 21-24
Time Frame
24 weeks
Title
Change from baseline in the number of days with cluster headache per week at week 9-12
Time Frame
12 weeks
Title
Change from baseline in the number of days with cluster headache per week at week 21-24
Time Frame
24 weeks
Title
Change from baseline in the number of hours with cluster headache per week at week 9-12
Time Frame
12 weeks
Title
Change from baseline in the number of hours with cluster headache per week at week 21-24
Time Frame
24 weeks
Title
Change from baseline in use of acute treatment per week at week 9-12
Time Frame
12 weeks
Title
Change from baseline in use of acute treatment per week at week 21-24
Time Frame
24 weeks
Title
Change from baseline in subjective sleep quality in week 12
Description
according to sleep diary
Time Frame
12 weeks
Title
Change from baseline in subjective sleep quality in week 24
Description
according to sleep diary
Time Frame
24 weeks
Title
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12
Time Frame
12 weeks
Title
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24
Time Frame
24 weeks
Title
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12
Time Frame
12 weeks
Title
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24
Time Frame
24 weeks
Title
Change from baseline in heat/cold pain thresholds at week 12 according to thermal test
Time Frame
12 weeks
Title
Change from baseline in pressure pain thresholds at week 12 according to algometry test
Time Frame
12 weeks
Title
Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.
Time Frame
24 weeks
Title
Change from baseline in pressure pain thresholds at week 24 according to algometry test
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geirmund Unsgård, MD PhD prof
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erling Tronvik, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Jacob Stovner, MD prof
Organizational Affiliation
Norwegian Advisory Unit on Headaches
Official's Role
Study Chair
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache
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