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Completed Not applicable Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT04029311

Public ClinicalTrials.gov record NCT04029311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04029311
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Joseph Adame
Individual
Enrollment
28 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 7, 2017
Primary completion
Feb 5, 2019
Completion
May 6, 2019
Last update posted
Apr 1, 2021

2017 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
J. Michael Adame, DDS, PA Edinburg Texas 78539

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04029311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 1, 2021 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04029311 live on ClinicalTrials.gov.

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