Clinical trial NCT04871581: Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device
Official title: Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine, Headache
Keywords: single blinded study
Lead sponsor: ChairsideSplint.com
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single blinded cross-over study
Primary purpose: PREVENTION

Brief summary: Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

Detailed description: In order to determine if nocturnal jaw clenching can be an influence on chronic migraine pain, the FDA cleared "NTI" (Nociceptive Trigeminal Inhibition) device with the Indications for Use of "for prophylactic treatment of medically diagnosed migraine pain" was compared to a similar device that had no influence on jaw clenching.The HIT-6 (Headache Impact Test) score was selected as the outcome measure, as the goal was to focus on improving disability in sufferer's lives, as in chronic migraine, changes in headache days may not be as helpful as improving disability.

Eligibility criteria: Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -

Exclusion Criteria: none

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Primary outcomes:
measure: Improvement of negative impact on life
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Solana Beach
country: United States
facility: Boyd James
state: California
Study officials:
References:
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