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出境医 / 临床实验 / Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

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

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:

  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

Condition or disease Intervention/treatment Phase
Treatment for Obstructive Sleep Apnea Device: Nuance Pro Device: autoPAP Device: TAP PAP Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : May 7, 2019
Arms and Interventions
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 Name: 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
Outcome Measures
Primary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: 2 months ]
    Episodes per hour that the patient experiences apneas and/or hypopneas

  2. PAP Pressure [ Time Frame: 2 months ]
    The pressure required to treat the patient successfully

  3. Leaks [ Time Frame: 2 months ]
    The Liters/Minute of leaking of the PAP machine

  4. Hours of Use [ Time Frame: 2 months ]
    The average hours of use per night of each of the combination therapies

  5. Epworth Sleepiness Scale (ESS) [ Time Frame: 2 months ]
    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.

  6. Functional Outcomes Sleep Questionnaire (FOSQ) [ Time Frame: 2 months ]
    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.

  7. Intolerance Questionnaire [ Time Frame: 2 months ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
United States, Texas
J. Michael Adame, DDS, PA
Edinburg, Texas, United States, 78539
Sponsors and Collaborators
Joseph Adame
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Results First Submitted Date  ICMJE February 9, 2021
Results First Posted Date  ICMJE April 2, 2021
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE June 8, 2017
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2021)
  • Apnea-Hypopnea Index [ Time Frame: 2 months ]
    Episodes per hour that the patient experiences apneas and/or hypopneas
  • PAP Pressure [ Time Frame: 2 months ]
    The pressure required to treat the patient successfully
  • Leaks [ Time Frame: 2 months ]
    The Liters/Minute of leaking of the PAP machine
  • Hours of Use [ Time Frame: 2 months ]
    The average hours of use per night of each of the combination therapies
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 2 months ]
    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) [ Time Frame: 2 months ]
    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 [ Time Frame: 2 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Apnea-Hypopnea Index [ Time Frame: 2 months ]
    Episodes per hour that the patient experiences apneas and/or hypopneas
  • PAP Pressure [ Time Frame: 2 months ]
    The cm H2O of pressure required to treat the patient successfully
  • Leaks [ Time Frame: 2 months ]
    The Liters/Minute of leaking of the PAP machine
  • Hours of Use [ Time Frame: 2 months ]
    The average hours of use per night of each of the combination therapies
  • ESS [ Time Frame: 2 months ]
    Epworth Sleepiness Scale (0-24) is a tool used to measure subjective response to a therapeutic intervention
  • FOSQ [ Time Frame: 2 months ]
    Functional Outcomes Sleep Questionnaire measures subjective response
  • Intolerance Questionnaire [ Time Frame: 2 months ]
    Series of questions which are typical of patients who experience intolerance to PAP therapy
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
Official Title  ICMJE Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
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. 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Treatment for Obstructive Sleep Apnea
Intervention  ICMJE
  • Device: Nuance Pro
    Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
    Other Name: TAP PAP
  • Device: autoPAP
    autoPAP
  • Device: TAP PAP
    TAP PAP
Study Arms  ICMJE
  • Experimental: Combination Therapy with Preferred Mask
    Preferred Mask refers to a type of existing medical mask used for PAP therapy.
    Interventions:
    • Device: Nuance Pro
    • Device: 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.
    Interventions:
    • Device: autoPAP
    • Device: TAP PAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2021) 		28
Original Actual Enrollment  ICMJE
 (submitted: July 22, 2019) 		30
Actual Study Completion Date  ICMJE May 7, 2019
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029311
Other Study ID Numbers  ICMJE 20170991
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joseph Adame, Adame, J. Michael, D.D.S.
Study Sponsor  ICMJE Joseph Adame
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adame, J. Michael, D.D.S.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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