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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP treatment | Experimental | Continuous Positive Airway Pressure (CPAP) |
|
| Sham-CPAP treatment | Sham Comparator | sham Continuous Positive Airway Pressure (sham-CPAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | standard automatic CPAP machine set on optimal automatic pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in number of cluster headache attacks per week at week 9-12 | 12 weeks | |
| change from baseline in number of cluster headache attacks per week at week 21-24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of nightly cluster attacks per week at week 9-12 | 12 weeks | |
| Change from baseline in the number of nightly cluster attacks per week at week 21-24 | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geirmund Unsgård, MD PhD prof | St. Olavs Hospital | Study Director |
| Erling Tronvik, MD PhD | Norwegian University of Science and Technology | Principal Investigator |
| Lars Jacob Stovner, MD prof | Norwegian Advisory Unit on Headaches | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36620891 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2024 | |
| Reset | Aug 16, 2024 | |
| Release | Jun 29, 2025 | |
| Reset | Jul 16, 2025 | |
| Release | Aug 4, 2025 | |
| Reset | Aug 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2024 | Aug 16, 2024 | |||
| Jun 29, 2025 |
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D002908 | Chronic Disease |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| 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 |
|
|
| Change from baseline in cluster headache start time per week at week 9-12 |
| 12 weeks |
| Change from baseline in cluster headache start time per week at week 21-24 | 24 weeks |
| Change from baseline in the number of days with cluster headache per week at week 9-12 | 12 weeks |
| Change from baseline in the number of days with cluster headache per week at week 21-24 | 24 weeks |
| Change from baseline in the number of hours with cluster headache per week at week 9-12 | 12 weeks |
| Change from baseline in the number of hours with cluster headache per week at week 21-24 | 24 weeks |
| Change from baseline in use of acute treatment per week at week 9-12 | 12 weeks |
| Change from baseline in use of acute treatment per week at week 21-24 | 24 weeks |
| Change from baseline in subjective sleep quality in week 12 | according to sleep diary | 12 weeks |
| Change from baseline in subjective sleep quality in week 24 | according to sleep diary | 24 weeks |
| Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 12 | 12 weeks |
| Change from the night of PSG registration in apnea-hypopnea index (AHI) during sleep to week 24 | 24 weeks |
| Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 12 | 12 weeks |
| Change from the night of PSG registration in oxygen desaturation index (ODI) during sleep to week 24 | 24 weeks |
| Change from baseline in heat/cold pain thresholds at week 12 according to thermal test | 12 weeks |
| Change from baseline in pressure pain thresholds at week 12 according to algometry test | 12 weeks |
| Change from baseline in heat/cold pain thresholds at week 24 according to thermal test. | 24 weeks |
| Change from baseline in pressure pain thresholds at week 24 according to algometry test | 24 weeks |
| Jul 16, 2025 |
| Aug 4, 2025 | Aug 20, 2025 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D012138 |
| Respiratory Therapy |