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

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ClinicalTrials.gov Identifier: NCT03397563
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease Intervention/treatment Phase
Cluster Headache Chronic Disease Device: Continuous Positive Airway Pressure Device: sham Continuous Positive Airway Pressure Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure as a Potential New Treatment for Cluster Headache - a Randomized Controlled Crossover Study
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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 Name: 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 Name: 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 Name: 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 Name: sham-CPAP




Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: 12 weeks ]
    according to sleep diary

  12. Change from baseline in subjective sleep quality in week 24 [ Time Frame: 24 weeks ]
    according to sleep diary

  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397563


Contacts
Contact: Gøril Bruvik Gravdahl +47 72575147 goril.b.gravdahl@ntnu.no
Contact: Erling Tronvik, MD PhD erling.tronvik@ntnu.no

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Gøril Bruvik Gravdahl       goril.b.gravdahl@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03397563     History of Changes
Other Study ID Numbers: 2017/1491
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Continuous Positive Airway Pressure
Sleep Apnea, Obstructive
Polysomnography

Additional relevant MeSH terms:
Headache
Chronic Disease
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases