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CompletedNCT03397563CPAPUpdated Mar 31, 2020

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

An interventional study of Continuous Positive Airway Pressure and sham Continuous Positive Airway Pressure in Cluster Headache and Chronic Disease, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cluster Headache
  • Chronic Disease

Keywords

  • Continuous Positive Airway Pressure
  • Sleep Apnea, Obstructive
  • Polysomnography
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 30 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.

Browse St. Olavs Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • disorders with 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CPAP treatment

    Continuous Positive Airway Pressure (CPAP)

    Device: Continuous Positive Airway Pressure · Device: sham Continuous Positive Airway Pressure

  • Sham comparator
    Sham-CPAP treatment

    sham Continuous Positive Airway Pressure (sham-CPAP)

    Device: Continuous Positive Airway Pressure · Device: sham Continuous Positive Airway Pressure

Interventions

  • DeviceContinuous Positive Airway Pressure

    standard automatic CPAP machine set on optimal automatic pressure

    Also known as: CPAP

  • Devicesham 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

    Also known as: sham-CPAP

06

What researchers measure

Primary outcomes

  1. change from baseline in number of cluster headache attacks per week at week 9-12

    Time frame: 12 weeks

  2. change from baseline in number of cluster headache attacks per week at week 21-24

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in the number of nightly cluster attacks per week at week 9-12

    Time frame: 12 weeks

  2. Change from baseline in the number of nightly cluster attacks per week at week 21-24

    Time frame: 24 weeks

  3. Change from baseline in cluster headache start time per week at week 9-12

    Time frame: 12 weeks

  4. Change from baseline in cluster headache start time per week at week 21-24

    Time frame: 24 weeks

  5. Change from baseline in the number of days with cluster headache per week at week 9-12

    Time frame: 12 weeks

  6. Change from baseline in the number of days with cluster headache per week at week 21-24

    Time frame: 24 weeks

  7. Change from baseline in the number of hours with cluster headache per week at week 9-12

    Time frame: 12 weeks

  8. Change from baseline in the number of hours with cluster headache per week at week 21-24

    Time frame: 24 weeks

  9. Change from baseline in use of acute treatment per week at week 9-12

    Time frame: 12 weeks

  10. Change from baseline in use of acute treatment per week at week 21-24

    Time frame: 24 weeks

  11. Change from baseline in subjective sleep quality in week 12

    according to sleep diary

    Time frame: 12 weeks

  12. Change from baseline in subjective sleep quality in week 24

    according to sleep diary

    Time frame: 24 weeks

  13. Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12

    Time frame: 12 weeks

  14. Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24

    Time frame: 24 weeks

  15. Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12

    Time frame: 12 weeks

  16. Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24

    Time frame: 24 weeks

  17. Change from baseline in heat/cold pain thresholds at week 12 according to thermal test

    Time frame: 12 weeks

  18. Change from baseline in pressure pain thresholds at week 12 according to algometry test

    Time frame: 12 weeks

  19. Change from baseline in heat/cold pain thresholds at week 24 according to thermal test.

    Time frame: 24 weeks

  20. Change from baseline in pressure pain thresholds at week 24 according to algometry test

    Time frame: 24 weeks

07

Study locations

1 site
  • St Olavs Hospital
    Trondheim, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Aug 2019, 19 months.

Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 19 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2018
First posted
Jan 12, 2018
StartActual
Jan 16, 2018
Primary completionActual
Aug 21, 2019
CompletionActual
Aug 21, 2019
Last update
Mar 31, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03397563
Lead sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
Jan 12, 2018
Start date
Jan 16, 2018
Primary completion
Aug 21, 2019
Completion
Aug 21, 2019
Last update
Mar 31, 2020

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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