CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Nuance Pro +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04029311
NCT04029311N/ACompleted

Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

Joseph Adame·interventional·Posted Jul 23, 2019·Updated Apr 2, 2021

In Brief

A clinical study evaluating Nuance Pro, autoPAP, and 1 other intervention for Treatment for Obstructive Sleep Apnea. Completed, enrolled 28 participants across 1 site.

Detailed Summary

To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy. Hypothesis 1\. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of: 1. Apnea Hypopnea Index (AHI) reduction 2. Amount of side effects 3. Amount of Leaks 4. Hours of use (compliance) 5. CPAP pressure 2\. There is a difference between connected and disconnected for the following symptoms: 1. Epworth sleepiness Scale (ESS) 2. Functional Outcomes of Sleep Questionnaire (FOSQ) 3. Side effects Study Design - randomized prospective parallel

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartJun 8, 2017
Primary CompletionFeb 6, 2019
Study CompletionMay 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.9 years ago

Interventions

Nuance Prodevice

Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP

autoPAPdevice

autoPAP

TAP PAPdevice

TAP PAP