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OpenTrials
Completed

NCT Number: NCT04029311

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

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Key information

Conditions

Treatment for Obstructive Sleep Apnea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

J. Michael Adame, DDS, PA

Edinburg, Texas, 78539, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nuance Pro

Device

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

Other names: TAP PAP

autoPAP

Device

autoPAP

TAP PAP

Device

TAP PAP

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Joseph Adame

Indiv

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.