NCT05511155

Brief Summary

Headache is one of the common causes of emergency department admissions and constitutes approximately 2%. Although the exact mechanism is not clear, It is known that high-flow oxygen therapy is effective in headache treatment. There are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. In this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

August 16, 2022

Last Update Submit

September 30, 2022

Conditions

Primary Headache Disorder

Keywords

oxygen therapymigraineemergency departmentcluster type headache

Outcome Measures

Primary Outcomes (1)

  • visual analog scale score

    primary endpoint is the relative reduction in visual analog scale (a psychometric response scale) score in the placebo versus oxygen group to determine whether there was a difference between the high-flow and mid-flow therapies. visual analog scale scaled from 0-100 points with 0 meaning "no pain" and 100 points meaning "worst possible pain".

    0-60 minutes

Secondary Outcomes (4)

  • rescue analgesia

    30 th minutes

  • length of stay

    0-300 minutes

  • duration of a pain

    0-300 minutes

  • readmission

    0-7 days

Study Arms (4)

O-15

15 lt/min oxygen

Other: Oxygen therapy

O-8

8 lt/min oxygen

Other: Oxygen therapy

A-15

15 lt/min room air

Other: Oxygen therapy

A-8

8 lt/min room air

Other: Oxygen therapy

Interventions

Oxygen therapyOTHER

Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.

A-15A-8O-15O-8

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

all patients had one to six headache attacks per month which were started before 50 years old and were present for more than one year.

You may qualify if:

  • age 18-55 years
  • frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria

You may not qualify if:

  • secondary headache disorders
  • oxygen-dependent chronic illnesses such as chronic obstructive pulmonary disease
  • a history of cerebrovascular disease
  • pregnancy
  • active smokers or living with a smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University Aksaray Training and Research Hospital

Aksaray, 68200, Turkey (Türkiye)

Location

Related Publications (4)

  • Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005.

    PMID: 19218020BACKGROUND

  • Roberto G, Raschi E, Piccinni C, Conti V, Vignatelli L, D'Alessandro R, De Ponti F, Poluzzi E. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015 Feb;35(2):118-31. doi: 10.1177/0333102414550416. Epub 2014 Sep 22.

    PMID: 25246519BACKGROUND

  • Mo H, Chung SJ, Rozen TD, Cho SJ. Oxygen Therapy in Cluster Headache, Migraine, and Other Headache Disorders. J Clin Neurol. 2022 May;18(3):271-279. doi: 10.3988/jcn.2022.18.3.271.

    PMID: 35589316BACKGROUND

  • Petersen AS, Barloese MC, Lund NL, Jensen RH. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study. Cephalalgia. 2017 Mar;37(3):214-224. doi: 10.1177/0333102416637817. Epub 2016 Jul 11.

    PMID: 27013239BACKGROUND

MeSH Terms

Conditions

Headache Disorders, PrimaryMigraine DisordersEmergencies

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 22, 2022

Study Start

July 1, 2022

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)