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Transnasal Cooling for Migraine

NCT04936061 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-09-29

Study results available
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Summary

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.

Conditions

  • Migraine
  • Episodic Migraine
  • Migraine With Aura
  • Migraine Without Aura

Interventions

DEVICE

CoolStat active device

The CoolStat active device will administer a therapeutic flow of dry air into the nostril.

DEVICE

CoolStat sham device

The CoolStat sham device will administer a sham flow of ambient air into the nostril.

Sponsors & Collaborators

  • CoolTech LLC

    lead INDUSTRY

Principal Investigators

  • Nauman Tariq, MD · Atrium Health Neurosciences Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-08-31
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936061 on ClinicalTrials.gov