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

NCT ID: NCT03397563

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2019-08-21

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.

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.

Conditions

Cluster Headache; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CPAP treatment

Continuous Positive Airway Pressure (CPAP)

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type: DEVICE

standard automatic CPAP machine set on optimal automatic pressure

sham Continuous Positive Airway Pressure

Intervention Type: DEVICE

CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask

Sham-CPAP treatment

sham Continuous Positive Airway Pressure (sham-CPAP)

Group Type: SHAM_COMPARATOR

Continuous Positive Airway Pressure

Intervention Type: DEVICE

standard automatic CPAP machine set on optimal automatic pressure

sham Continuous Positive Airway Pressure

Intervention Type: DEVICE

CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask

Interventions

Continuous Positive Airway Pressure

standard automatic CPAP machine set on optimal automatic pressure

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

CPAP; sham-CPAP

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geirmund Unsgård, MD PhD prof

Role: STUDY_DIRECTOR

St. Olavs Hospital

Erling Tronvik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Lars Jacob Stovner, MD prof

Role: STUDY_CHAIR

Norwegian Advisory Unit on Headaches

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 36620891 (View on PubMed)

Other Identifiers

2017/1491

Identifier Type: -

Identifier Source: org_study_id