Cluster HeadacheCPAPNCT03397563
Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache
A study testing Continuous Positive Airway Pressure in people with Cluster Headache and Chronic Disease, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cluster Headache, Chronic Disease
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 16 Jan 2018to 21 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Continuous Positive Airway Pressure, sham Continuous Positive Airway Pressure
- Keywords
- Continuous Positive Airway Pressure, Sleep Apnea, Obstructive, Polysomnography
- Medical subject headings
- Cluster Headache, Chronic Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Also called CPAP
standard automatic CPAP machine set on optimal automatic pressure
sham Continuous Positive Airway PressureDevice
Also called sham-CPAP
CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Continuous Positive Airway Pressure (CPAP) Receives: Device: Continuous Positive Airway Pressure; Device: sham Continuous Positive Airway Pressure |
| Sham-CPAP treatment | Sham comparator | sham Continuous Positive Airway Pressure (sham-CPAP) Receives: Device: Continuous Positive Airway Pressure; Device: sham Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in number of cluster headache attacks per week at week 9-12
Measured: 12 weeks
change from baseline in number of cluster headache attacks per week at week 21-24
Measured: 24 weeks
Secondary outcomes (20)
Change from baseline in the number of nightly cluster attacks per week at week 9-12
Measured: 12 weeks
Change from baseline in the number of nightly cluster attacks per week at week 21-24
Measured: 24 weeks
Change from baseline in cluster headache start time per week at week 9-12
Measured: 12 weeks
Change from baseline in cluster headache start time per week at week 21-24
Measured: 24 weeks
Change from baseline in the number of days with cluster headache per week at week 9-12
Measured: 12 weeks
Change from baseline in the number of days with cluster headache per week at week 21-24
Measured: 24 weeks
Change from baseline in the number of hours with cluster headache per week at week 9-12
Measured: 12 weeks
Change from baseline in the number of hours with cluster headache per week at week 21-24
Measured: 24 weeks
Change from baseline in use of acute treatment per week at week 9-12
Measured: 12 weeks
Change from baseline in use of acute treatment per week at week 21-24
Measured: 24 weeks
Change from baseline in subjective sleep quality in week 12
according to sleep diary
Measured: 12 weeks
Change from baseline in subjective sleep quality in week 24
according to sleep diary
Measured: 24 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12
Measured: 12 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24
Measured: 24 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12
Measured: 12 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24
Measured: 24 weeks
Change from baseline in heat/cold pain thresholds at week 12 according to thermal test
Measured: 12 weeks
Change from baseline in pressure pain thresholds at week 12 according to algometry test
Measured: 12 weeks
Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.
Measured: 24 weeks
Change from baseline in pressure pain thresholds at week 24 according to algometry test
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start16 Jan 2018
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Geirmund Unsgård, MD PhD prof, Study director, St. Olavs HospitalErling Tronvik, MD PhD, Principal investigator, Norwegian University of Science and TechnologyLars Jacob Stovner, MD prof, Study chair, Norwegian Advisory Unit on Headaches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397563
- Sponsor's protocol ID
- 2017/1491
- Acronym
- CPAP
- Status last verified
- Mar 2020
- First submitted
- 4 Jan 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gravdahl GB, Aakeroy L, Stovner LJ, Engstrom M, Muller KI, Bjork MH, Tronvik E. Continuous positive airway pressure in cluster headache: A randomized, placebo-controlled, triple-blind, crossover study. Cephalalgia. 2023 Jan;43(1):3331024221128273. doi: 10.1177/03331024221128273.
PubMed 36620891
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache - a Randomized Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03397563
- Acronym / sponsor ID
- CPAP / 2017/1491
- Conditions
- Cluster Headache, Chronic Disease
- Keywords
- Continuous Positive Airway Pressure, Sleep Apnea, Obstructive, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous Positive Airway Pressure, Device: sham Continuous Positive Airway PressureContinuous Positive Airway Pressure (CPAP) |
| Sham-CPAP treatment | Sham comparator | Device: Continuous Positive Airway Pressure, Device: sham Continuous Positive Airway Pressuresham Continuous Positive Airway Pressure (sham-CPAP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureAlso: CPAPstandard automatic CPAP machine set on optimal automatic pressure | Device | CPAP treatment, Sham-CPAP treatment |
| sham Continuous Positive Airway PressureAlso: sham-CPAPCPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask | Device | CPAP treatment, Sham-CPAP treatment |
Primary outcome
change from baseline in number of cluster headache attacks per week at week 9-12
Time frame: 12 weeks
change from baseline in number of cluster headache attacks per week at week 21-24
Time frame: 24 weeks
20 secondary outcomes
Change from baseline in the number of nightly cluster attacks per week at week 9-12
Time frame: 12 weeks
Change from baseline in the number of nightly cluster attacks per week at week 21-24
Time frame: 24 weeks
Change from baseline in cluster headache start time per week at week 9-12
Time frame: 12 weeks
Change from baseline in cluster headache start time per week at week 21-24
Time frame: 24 weeks
Change from baseline in the number of days with cluster headache per week at week 9-12
Time frame: 12 weeks
Change from baseline in the number of days with cluster headache per week at week 21-24
Time frame: 24 weeks
Change from baseline in the number of hours with cluster headache per week at week 9-12
Time frame: 12 weeks
Change from baseline in the number of hours with cluster headache per week at week 21-24
Time frame: 24 weeks
Change from baseline in use of acute treatment per week at week 9-12
Time frame: 12 weeks
Change from baseline in use of acute treatment per week at week 21-24
Time frame: 24 weeks
Change from baseline in subjective sleep quality in week 12
Time frame: 12 weeks
Change from baseline in subjective sleep quality in week 24
Time frame: 24 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12
Time frame: 12 weeks
Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24
Time frame: 24 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12
Time frame: 12 weeks
Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24
Time frame: 24 weeks
Change from baseline in heat/cold pain thresholds at week 12 according to thermal test
Time frame: 12 weeks
Change from baseline in pressure pain thresholds at week 12 according to algometry test
Time frame: 12 weeks
Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.
Time frame: 24 weeks
Change from baseline in pressure pain thresholds at week 24 according to algometry test
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 36620891Gravdahl GB, Aakeroy L, Stovner LJ, Engstrom M, Muller KI, Bjork MH, Tronvik E. Continuous positive airway pressure in cluster headache: A randomized, placebo-controlled, triple-blind, crossover study. Cephalalgia. 2023 Jan;43(1):3331024221128273. doi: 10.1177/03331024221128273.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geirmund Unsgård, MD PhD prof study director
St. Olavs Hospital
Erling Tronvik, MD PhD principal investigator
Norwegian University of Science and Technology
Lars Jacob Stovner, MD prof study chair
Norwegian Advisory Unit on Headaches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Cluster Headache and Chronic Disease, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in number of cluster headache attacks per week at week 9-12 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.