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

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 Overview

• Status: Completed
• Conditions: Treatment for Obstructive Sleep Apnea
• Intervention / Treatment: Device: Nuance Pro; Device: autoPAP; Device: TAP PAP

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Edinburg, Texas, United States, 78539
      • J. Michael Adame, DDS, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: Baseline diagnosis AHI > or = 5 plus ESS . or = 10.

• PAP Intolerance
• Partial Response to oral appliance therapy: AHI > 5
• Age: > 18 Exclusion Criteria: History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants.
• Diagnosis of Central Sleep Apnea
• Pregnancy
• Edentulous
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy with Preferred Mask; Preferred Mask refers to a type of existing medical mask used for PAP therapy.	Device: Nuance Pro; Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP; Other Names: TAP PAP; Device: autoPAP; autoPAP
Experimental: Combination Therapy with Custom Mask; Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.	Device: autoPAP; autoPAP; Device: TAP PAP; TAP PAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index	Episodes per hour that the patient experiences apneas and/or hypopneas	2 months
PAP Pressure	The pressure required to treat the patient successfully	2 months
Leaks	The Liters/Minute of leaking of the PAP machine	2 months
Hours of Use	The average hours of use per night of each of the combination therapies	2 months
Epworth Sleepiness Scale (ESS)	The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.	2 months
Functional Outcomes Sleep Questionnaire (FOSQ)	FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.	2 months
Intolerance Questionnaire	This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.	2 months

Collaborators and Investigators

• Sponsor: Joseph Adame

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): February 6, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20170991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes