NCT04029311

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:

  1. 1.Apnea Hypopnea Index (AHI) reduction
  2. 2.Amount of side effects
  3. 3.Amount of Leaks
  4. 4.Hours of use (compliance)
  5. 5.CPAP pressure
  6. 6.Epworth sleepiness Scale (ESS)
  7. 7.Functional Outcomes of Sleep Questionnaire (FOSQ)
  8. 8.Side effects Study Design - randomized prospective parallel

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

July 19, 2019

Results QC Date

February 9, 2021

Last Update Submit

March 8, 2021

Conditions

Treatment for Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Combination Therapy with Preferred Mask

EXPERIMENTAL

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

Device: Nuance ProDevice: autoPAP

Combination Therapy with Custom Mask

EXPERIMENTAL

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

Device: autoPAPDevice: TAP PAP

Interventions

Nuance ProDEVICE

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

Also known as: TAP PAP
Combination Therapy with Preferred Mask
autoPAPDEVICE

autoPAP

Combination Therapy with Custom MaskCombination Therapy with Preferred Mask
TAP PAPDEVICE

TAP PAP

Combination Therapy with Custom Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PAP Intolerance
  • Partial Response to oral appliance therapy: AHI \> 5

You may not qualify if:

  • Diagnosis of Central Sleep Apnea
  • Pregnancy
  • Edentulous
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J. Michael Adame, DDS, PA

Edinburg, Texas, 78539, United States

Location

Results Point of Contact

Title
Dr. Yasue Tanaka
Organization
Tohoku University
yasue.tanaka.b3@tohoku.ac.jp
+81227178396

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
J. Michael Adame, DDS, Principal Investigator

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 23, 2019

Study Start

June 8, 2017

Primary Completion

February 6, 2019

Study Completion

May 7, 2019

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)