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Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eucalyptus Oil Scent
Isopropyl Alcohol Vapors
Sponsored by
HonorHealth Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraine focused on measuring Nausea, Isopropyl alcohol, Eucalyptus, Aromatherapy, Vapors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 to 65 years old with nausea associated migraines at least twice per month

Exclusion Criteria:

  • Patients <18 or >65 years old
  • Patients without a diagnosis of acute migraine

Sites / Locations

  • HonorHealth Bob Bové Neuroscience InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Eucalyptus Oil Scent

Isopropyl Alcohol Vapors

Arm Description

Eucalyptus oil diluted in mineral oil 1:20

Isopropyl Alcohol 70%

Outcomes

Primary Outcome Measures

Change of Severity of Nausea on Nausea Scale
Change in Nausea, modified visual analog score from 0-10 with 10 severe nausea with vomiting, 5 moderate nausea, 1 mild nausea and 0 no nausea.

Secondary Outcome Measures

Side effects associated with interventional substance
Patient written report
Use of anti-nausea medication/Time to use of anti-nausea medication
Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic?
Time to Clinically Relevant Nausea Change
Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine?

Full Information

First Posted
August 19, 2021
Last Updated
October 18, 2023
Sponsor
HonorHealth Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05175521
Brief Title
Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine
Official Title
Double Blind Randomized Control Trial of Inhaled Isopropyl Alcohol Vapors Versus Inhaled Eucalyptus Scent for the Treatment of Nausea Associated With Acute Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
July 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.
Detailed Description
The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Nausea, Isopropyl alcohol, Eucalyptus, Aromatherapy, Vapors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eucalyptus Oil Scent
Arm Type
Placebo Comparator
Arm Description
Eucalyptus oil diluted in mineral oil 1:20
Arm Title
Isopropyl Alcohol Vapors
Arm Type
Active Comparator
Arm Description
Isopropyl Alcohol 70%
Intervention Type
Other
Intervention Name(s)
Eucalyptus Oil Scent
Intervention Description
Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack
Intervention Type
Other
Intervention Name(s)
Isopropyl Alcohol Vapors
Intervention Description
Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack
Primary Outcome Measure Information:
Title
Change of Severity of Nausea on Nausea Scale
Description
Change in Nausea, modified visual analog score from 0-10 with 10 severe nausea with vomiting, 5 moderate nausea, 1 mild nausea and 0 no nausea.
Time Frame
½ hour or to the end of treatment
Secondary Outcome Measure Information:
Title
Side effects associated with interventional substance
Description
Patient written report
Time Frame
½ hour, but likely less than 2 hours
Title
Use of anti-nausea medication/Time to use of anti-nausea medication
Description
Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic?
Time Frame
½ hour or to the end of treatment
Title
Time to Clinically Relevant Nausea Change
Description
Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine?
Time Frame
½ hour or to the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 to 65 years old with nausea associated migraines at least twice per month Exclusion Criteria: Patients <18 or >65 years old Patients without a diagnosis of acute migraine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Cooper
Phone
480-583-3193
Email
ancooper@honorhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Rau, MD, PhD
Organizational Affiliation
HonorHealth Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Bob Bové Neuroscience Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Cooper
Phone
480-583-3193
Email
ancooper@honorhealth.com

12. IPD Sharing Statement

Learn more about this trial

Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine

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