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

Primary Purpose

Treatment for Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nuance Pro
autoPAP
TAP PAP
Sponsored by
Joseph Adame
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • J. Michael Adame, DDS, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Combination Therapy with Preferred Mask

Combination Therapy with Custom Mask

Arm Description

Preferred Mask refers to a type of existing medical mask used for PAP therapy.

Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
Episodes per hour that the patient experiences apneas and/or hypopneas
PAP Pressure
The pressure required to treat the patient successfully
Leaks
The Liters/Minute of leaking of the PAP machine
Hours of Use
The average hours of use per night of each of the combination therapies
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2019
Last Updated
March 8, 2021
Sponsor
Joseph Adame
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1. Study Identification

Unique Protocol Identification Number
NCT04029311
Brief Title
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Official Title
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Adame

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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: Apnea Hypopnea Index (AHI) reduction Amount of side effects Amount of Leaks Hours of use (compliance) CPAP pressure 2. There is a difference between connected and disconnected for the following symptoms: Epworth sleepiness Scale (ESS) Functional Outcomes of Sleep Questionnaire (FOSQ) Side effects Study Design - randomized prospective parallel

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment for Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Therapy with Preferred Mask
Arm Type
Experimental
Arm Description
Preferred Mask refers to a type of existing medical mask used for PAP therapy.
Arm Title
Combination Therapy with Custom Mask
Arm Type
Experimental
Arm Description
Custom Mask refers to a mask which is supported by an interface which attaches directly to the patient's oral appliance.
Intervention Type
Device
Intervention Name(s)
Nuance Pro
Other Intervention Name(s)
TAP PAP
Intervention Description
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
Intervention Type
Device
Intervention Name(s)
autoPAP
Intervention Description
autoPAP
Intervention Type
Device
Intervention Name(s)
TAP PAP
Intervention Description
TAP PAP
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Episodes per hour that the patient experiences apneas and/or hypopneas
Time Frame
2 months
Title
PAP Pressure
Description
The pressure required to treat the patient successfully
Time Frame
2 months
Title
Leaks
Description
The Liters/Minute of leaking of the PAP machine
Time Frame
2 months
Title
Hours of Use
Description
The average hours of use per night of each of the combination therapies
Time Frame
2 months
Title
Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
2 months
Title
Functional Outcomes Sleep Questionnaire (FOSQ)
Description
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.
Time Frame
2 months
Title
Intolerance Questionnaire
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
J. Michael Adame, DDS, PA
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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