Primary Headache DisorderNCT05511155
Oxygen Therapy for Headache
An observational study of Primary Headache Disorder, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Primary Headache Disorder
- What is being tested?
- Oxygen therapy
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- age 18-55 years
- frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aksaray University Aksaray Training and Research Hospital
Aksaray, 68200
About this study
Official title: Efficacy of Oxygen Therapy in Primary Headache Disorder
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.
Read the detailed description
Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be applied to all patients included in the study. One of the four treatments will be randomly applied at each separate ED admission with a gap of 1 week or more in between. This randomization will be performed by a computer at the time of admission. A study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. Additional analgesia is at the discretion of the treating physician. Patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.
- Conditions
- Primary Headache Disorder
- Being tested
- Oxygen therapy
- Keywords
- oxygen therapy, migraine, emergency department, cluster type headache
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapyOther
Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
| Study group | Role | What they receive |
|---|---|---|
| O-15 | 15 lt/min oxygen Receives: Other: Oxygen therapy | |
| O-8 | 8 lt/min oxygen Receives: Other: Oxygen therapy | |
| A-15 | 15 lt/min room air Receives: Other: Oxygen therapy | |
| A-8 | 8 lt/min room air Receives: Other: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 0-60 minutes
Secondary outcomes (4)
rescue analgesia
rescue analgesia (yes/no)
Measured: 30 th minutes
length of stay
length of stay in the emergency department (time in minutes)
Measured: 0-300 minutes
duration of a pain
duration of a pain attack (time in minutes)
Measured: 0-300 minutes
readmission
readmission to the emergency department within 7 days (yes/no)
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jul 2022
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Headache DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilker kacer, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511155
- Sponsor's protocol ID
- 64-SBKAEK
- Status last verified
- Sep 2022
- First submitted
- 16 Aug 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19218020Roberto 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.
PubMed 25246519Mo 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.
PubMed 35589316Petersen 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.
PubMed 27013239
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oxygen Therapy in Primary Headache Disorder
- ClinicalTrials.gov ID
- NCT05511155
- Acronym / sponsor ID
- 64-SBKAEK
- Conditions
- Primary Headache Disorder
- Keywords
- oxygen therapy, migraine, emergency department, cluster type headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be applied to all patients included in the study. One of the four treatments will be randomly applied at each separate ED admission with a gap of 1 week or more in between. This randomization will be performed by a computer at the time of admission. A study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. Additional analgesia is at the discretion of the treating physician. Patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| O-15 | – | Other: Oxygen therapy15 lt/min oxygen |
| O-8 | – | Other: Oxygen therapy8 lt/min oxygen |
| A-15 | – | Other: Oxygen therapy15 lt/min room air |
| A-8 | – | Other: Oxygen therapy8 lt/min room air |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- age 18-55 years
- frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen therapyOxygen therapy will be given for 15 minutes with a non-rebreathing mask. | Other | A-15, A-8, O-15, O-8 |
Primary outcome
visual analog scale score
Time frame: 0-60 minutes
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".
4 secondary outcomes
rescue analgesia
Time frame: 30 th minutes
length of stay
Time frame: 0-300 minutes
duration of a pain
Time frame: 0-300 minutes
readmission
Time frame: 0-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 19218020Friedman 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.
- Background: PubMed 25246519Roberto 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.
- Background: PubMed 35589316Mo 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.
- Background: PubMed 27013239Petersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Headache Disorder, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale score (time frame: 0-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511155, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.