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AVPI Migraine Study

NCT05537818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-10

No results posted yet for this study

Summary

The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups:

* Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
* Phase II - for further evaluation when used in the home (non-clinical) environment.

Conditions

Interventions

DEVICE

AVPI Device

The AVPI device system consists of a small, hand-held, micro-pressure pulse generator device that is operated by a hand-held mobile smartphone (iPhone®) with a downloaded software application or "app." The AVPI device is connected to an earpiece assembly that splits into two earbuds (right and left) that seat comfortably into each respective ear. 1. AVPI device for pressure regulation 2. Earpiece Assembly - a small, flexible, hollow tube that divides into right and left earpieces 3. Earbuds - replaceable, multiple sizes 4. Smartphone with the AVPI app

Sponsors & Collaborators

  • Nocira, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-12-31
Completion
2024-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05537818 on ClinicalTrials.gov