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

NCT03397563 | Completed

• 1 other identifier: 2017/1491
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache; Chronic Disease

Keywords

Continuous Positive Airway Pressure; Sleep Apnea, Obstructive; Polysomnography

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (20)

• 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

• 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

Study Arms (2)

CPAP treatment

EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Device: Continuous Positive Airway Pressure; Device: sham Continuous Positive Airway Pressure

Sham-CPAP treatment

SHAM COMPARATOR

sham Continuous Positive Airway Pressure (sham-CPAP)

Device: Continuous Positive Airway Pressure; Device: sham Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

standard automatic CPAP machine set on optimal automatic pressure

Also known as: CPAP

CPAP treatment; Sham-CPAP treatment

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

Also known as: sham-CPAP

CPAP treatment; Sham-CPAP treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Severe depression or other psychiatric disorder that may interfere with the treatment.
• Abuse of alcohol or illicit drugs.
• Other severe chronic pain conditions

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 36620891 DERIVED

MeSH Terms

Conditions

Cluster Headache; Chronic Disease; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 12, 2018
• Study Start: January 16, 2018
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)