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Completed

NCT Number: NCT03397563

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

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.

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Key information

Conditions

Cluster Headache Apnea Brain Diseases Central Nervous System Diseases Chronic Disease Disease Attributes Dyssomnias Headache Disorders Headache Disorders, Primary Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Trigeminal Autonomic Cephalalgias

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

standard automatic CPAP machine set on optimal automatic pressure

Other names: CPAP

Sham continuous positive airway pressure

Device

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

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

    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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Acronym: CPAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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