RELAXaHEAD for Headache Patients (Phase III)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06077838
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • RELAXaHEAD Smartphone App Version 1 — BEHAVIORAL
    RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
  • RELAXaHEAD Smartphone App Version 2 — BEHAVIORAL
    RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.

Study Details

This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.

Key Dates

Start date
Nov 8, 2023
Status verified
Oct 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: RELAX Group 1
    Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.
  • Active Comparator: RELAX Group 2
    Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.

Primary Outcome Measure

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score [ Time Frame: Baseline, Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Migraine
By specialty
Neurology
By research site
NYU Langone Health· New York, NY

Related Studies