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Intervention (single arm) for Obstructive Sleep Apnea (FISATABI Trial)

N/A
Waitlist Available
Led By Marc A Silva, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention (roughly 4-8 weeks after enrollment)
Awards & highlights

FISATABI Trial Summary

This trial will test the feasibility of a 4-session manualized intervention, designed with cognitive accommodations, and informed by Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT), to address positive airway pressure (PAP) adherence in Veterans with moderate-to-severe traumatic brain injury (TBI) and obstructive sleep apnea (OSA).

Eligible Conditions
  • Obstructive Sleep Apnea
  • Traumatic Brain Injury

FISATABI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention (roughly 4-8 weeks after enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (roughly 4-8 weeks after enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Narrative Evaluation of Intervention Interview
Secondary outcome measures
Epworth Sleepiness Scale
Fatigue Severity Scale
Functional Outcomes of Sleep Questionnaire

FISATABI Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention (single arm)Experimental Treatment1 Intervention
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MI and CBT 4-session manualized intervention
2020
N/A
~20

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,167 Total Patients Enrolled
James A. Haley Veterans Administration HospitalFED
20 Previous Clinical Trials
13,149 Total Patients Enrolled
Marc A Silva, PhDPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury
2020. "Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04221009.
~4 spots leftby Apr 2025
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