Transnasal Therapy for Acute Migraine Attack

NCT04129567 | Completed DMC

• 1 other identifier: IRB00166706
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Migraine Disorders

Keywords

Trans-nasal; acute; migraine

Outcome Measures

Primary Outcomes (1)

• change in pain score as assessed on the VAS scale

  Graded on a scale of 1-10 where higher scores mean more pain.

  2 hours and 24 hours

Secondary Outcomes (3)

• change in nausea score as assessed on the VAS scale

  2 hours and 24 hours

• change in light sensitivity score as assessed on the VAS scale

  2 hours and 24 hours

• change in sound sensitivity score as assessed on the VAS scale

  2 hours and 24 hours

Study Arms (4)

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.

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.

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.

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.

Other: Dry oxygen

Interventions

Humidified oxygen OTHER

Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

Humidified oxygen

Dry oxygen OTHER

Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

Dry oxygen

Humidified air OTHER

Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

Humidified air

Dry air OTHER

Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

Dry air

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR)

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 33631965 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nauman Tariq, MD

  Johns Hopkins Neurology (Bayview)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: August 15, 2018
• Primary Completion: October 31, 2019
• Study Completion: November 15, 2019
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

US (1)