Migraine DisordersNCT04129567
Transnasal Therapy for Acute Migraine Attack
A study testing Humidified oxygen, Dry oxygen and Humidified air in people with Migraine Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
Migraine is a significant health problem in the United States with 34 million Americans suffering from migraine attacks every year. High-flow oxygen has been successfully used in several clinical studies. Vasoconstriction of blood vessels in the scalp has been proposed as a possible mechanism of action. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Humidified oxygen, Dry oxygen and Humidified air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 15 Nov 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Migraine diagnosis of at least 1 year
- Migraine attacks between 1 and 15 per month
- Onset of first migraine < 50 years of age
- Migraine prophylaxis medication unchanged for 3 months prior to enrollment
- Meets international classification for headache disorders criteria for diagnosis of episodic migraine with or without aura
- Able to attend a short treatment session within half hour of onset of headache.
Who cannot join
- Known oxygen dependency to maintain arterial oxygen saturation (SaO2) >95%
- Known marked nasal septal deviation
- Recurrent epistaxis or chronic Rhino-Sinusitis
- Concurrent sinus/intranasal surgery
- Unable to fully understand the consent process and informed consent due to either language barriers or mental capacity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR)
Baltimore, Maryland, 21224
About this study
Migraine is a significant health problem in the United States with 34 million Americans suffering from migraine attacks every year. High-flow oxygen has been successfully used in several clinical studies. Vasoconstriction of blood vessels in the scalp has been proposed as a possible mechanism of action. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief. The main objective is to test the hypothesis that the pain relief obtained during high-flow trans-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. The study entails recruiting patients from a headache clinic, being escorted to the Institute for Clinical and Translational Research (ICTR) Johns Hopkins Bayview and randomized into different groups (humidified oxygen, dry air, humidified air and dry oxygen). Eventually, patients will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity graded on a scale of 1-10. Readings are noted at baseline, 15 mins, 2 hours and 24 hours post-therapy.
Read the detailed description
Migraine headaches are associated with significant impairment of quality of life and loss of productivity. High-flow oxygen has been successfully used in several clinical trials and vasoconstriction of blood vessels has been postulated as a possible mechanism. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief.The main objective is to test the hypothesis that the pain relief obtained during high-flow intra-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. Participants for this study are recruited from the pool of patients who are already scheduled to attend the headache clinic staffed by the principal investigator. The PI will recruit patients at the Headache Clinic. The patients are escorted to the Clinical Trials Unit (CTU) at the Johns Hopkins Bayview where therapy its provided and will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity using a visual analog score (VAS) for each symptom on a scale of 1-10. The patients will be randomized to either humidified oxygen, dry air, humidified air or dry oxygen. Patients will be asked to submit readings at the end of therapy, at 2 hours and 24 hours post-therapy. Treatment failure is defined as persistent headache despite treatment with oxygen or air. Participants will be removed from the trial if participants prematurely terminate therapy.
The investigators believe that using a total sample size of 45 patients, the investigators will be able to show a statistically significant difference of >2 point change in the VAS pain score reduction between the two treatment groups with a confidence of 80%. No risk were reported in prior studies involving >100 patients and >500 episodes of treatment with air or oxygen. Because of the (at least 2 and 1/2 hour) delay in initiating standard of care treatments, subjects may experience a longer duration and/or intensity of pain from the headache than regular standards of care i.e., sooner. Participants will be reimbursed for participation in this study which will compensate travel and parking.
- Conditions
- Migraine Disorders
- Being tested
- Humidified oxygen, Dry oxygen, Humidified air, Dry air
- Keywords
- Trans-nasal, acute, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified oxygenOther
Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
Dry oxygenOther
Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
Humidified airOther
Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
Dry airOther
Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Humidified oxygen | Experimental | Delivering humidified oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. Receives: Other: Humidified oxygen |
| Dry air | Experimental | Delivering dry air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. Receives: Other: Dry air |
| Humidified air | Placebo comparator | Delivering humidified air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. Receives: Other: Humidified air |
| Dry oxygen | Active comparator | Delivering dry oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. Receives: Other: Dry oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain score as assessed on the VAS scale
Graded on a scale of 1-10 where higher scores mean more pain.
Measured: 2 hours and 24 hours
Secondary outcomes (3)
change in nausea score as assessed on the VAS scale
Graded on a scale of 1-10 where higher scores mean more nausea.
Measured: 2 hours and 24 hours
change in light sensitivity score as assessed on the VAS scale
Graded on a scale of 1-10 where higher scores mean more light sensitivity.
Measured: 2 hours and 24 hours
change in sound sensitivity score as assessed on the VAS scale
Graded on a scale of 1-10 where higher scores mean more sound sensitivity.
Measured: 2 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Aug 2018
- Primary completion31 Oct 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nauman Tariq, MD, Principal investigator, Johns Hopkins Neurology (Bayview)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129567
- Sponsor's protocol ID
- IRB00166706
- Status last verified
- Jul 2020
- First submitted
- 15 Oct 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shah R, Assis F, Narasimhan B, Khachadourian V, Zhou S, Tandri H, Tariq N. Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial. Cephalalgia. 2021 Aug;41(9):968-978. doi: 10.1177/0333102421997766. Epub 2021 Feb 25.
PubMed 33631965
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Therapy for Acute Migraine Attack
- ClinicalTrials.gov ID
- NCT04129567
- Acronym / sponsor ID
- IRB00166706
- Conditions
- Migraine Disorders
- Keywords
- Trans-nasal, acute, migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 17 Oct 2019 (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.
Migraine is a significant health problem in the United States with 34 million Americans suffering from migraine attacks every year. High-flow oxygen has been successfully used in several clinical studies. Vasoconstriction of blood vessels in the scalp has been proposed as a possible mechanism of action. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief. The main objective is to test the hypothesis that the pain relief obtained during high-flow trans-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. The study entails recruiting patients from a headache clinic, being escorted to the Institute for Clinical and Translational Research (ICTR) Johns Hopkins Bayview and randomized into different groups (humidified oxygen, dry air, humidified air and dry oxygen). Eventually, patients will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity graded on a scale of 1-10. Readings are noted at baseline, 15 mins, 2 hours and 24 hours post-therapy.
Detailed description
Migraine headaches are associated with significant impairment of quality of life and loss of productivity. High-flow oxygen has been successfully used in several clinical trials and vasoconstriction of blood vessels has been postulated as a possible mechanism. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief.The main objective is to test the hypothesis that the pain relief obtained during high-flow intra-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. Participants for this study are recruited from the pool of patients who are already scheduled to attend the headache clinic staffed by the principal investigator. The PI will recruit patients at the Headache Clinic. The patients are escorted to the Clinical Trials Unit (CTU) at the Johns Hopkins Bayview where therapy its provided and will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity using a visual analog score (VAS) for each symptom on a scale of 1-10. The patients will be randomized to either humidified oxygen, dry air, humidified air or dry oxygen. Patients will be asked to submit readings at the end of therapy, at 2 hours and 24 hours post-therapy. Treatment failure is defined as persistent headache despite treatment with oxygen or air. Participants will be removed from the trial if participants prematurely terminate therapy.
The investigators believe that using a total sample size of 45 patients, the investigators will be able to show a statistically significant difference of >2 point change in the VAS pain score reduction between the two treatment groups with a confidence of 80%. No risk were reported in prior studies involving >100 patients and >500 episodes of treatment with air or oxygen. Because of the (at least 2 and 1/2 hour) delay in initiating standard of care treatments, subjects may experience a longer duration and/or intensity of pain from the headache than regular standards of care i.e., sooner. Participants will be reimbursed for participation in this study which will compensate travel and parking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Humidified oxygen | Experimental | Other: Humidified oxygenDelivering humidified oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. |
| Dry air | Experimental | Other: Dry airDelivering dry air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. |
| Humidified air | Placebo comparator | Other: Humidified airDelivering humidified air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. |
| Dry oxygen | Active comparator | Other: Dry oxygenDelivering dry oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Migraine diagnosis of at least 1 year
- Migraine attacks between 1 and 15 per month
- Onset of first migraine < 50 years of age
- Migraine prophylaxis medication unchanged for 3 months prior to enrollment
- Meets international classification for headache disorders criteria for diagnosis of episodic migraine with or without aura
Key exclusion criteria (5 listed)
- Known oxygen dependency to maintain arterial oxygen saturation (SaO2) >95%
- Known marked nasal septal deviation
- Recurrent epistaxis or chronic Rhino-Sinusitis
- Concurrent sinus/intranasal surgery
- Unable to fully understand the consent process and informed consent due to either language barriers or mental capacity.
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 |
|---|---|---|
| Humidified oxygenDelivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula. | Other | Humidified oxygen |
| Dry oxygenDelivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula. | Other | Dry oxygen |
| Humidified airDelivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula. | Other | Humidified air |
| Dry airDelivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula. | Other | Dry air |
Primary outcome
change in pain score as assessed on the VAS scale
Time frame: 2 hours and 24 hours
Graded on a scale of 1-10 where higher scores mean more pain.
3 secondary outcomes
change in nausea score as assessed on the VAS scale
Time frame: 2 hours and 24 hours
change in light sensitivity score as assessed on the VAS scale
Time frame: 2 hours and 24 hours
change in sound sensitivity score as assessed on the VAS scale
Time frame: 2 hours and 24 hours
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 17 Jul 2020.
- Derived from this study: PubMed 33631965Shah R, Assis F, Narasimhan B, Khachadourian V, Zhou S, Tandri H, Tariq N. Trans-nasal high-flow dehumidified air in acute migraine headaches: A randomized controlled trial. Cephalalgia. 2021 Aug;41(9):968-978. doi: 10.1177/0333102421997766. Epub 2021 Feb 25.
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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.
Nauman Tariq, MD principal investigator
Johns Hopkins Neurology (Bayview)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidified oxygen, Dry oxygen and Humidified air in people with Migraine Disorders, run by Johns Hopkins University at 1 site in United States.
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 6 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 17 Jul 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
change in pain score as assessed on the VAS scale (time frame: 2 hours and 24 hours). 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 NCT04129567, which also lists 1 linked publication.
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 17 Jul 2020.