Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
NCT ID: NCT04029311
Last Updated: 2021-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2017-06-08
2019-05-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Combination Therapy with Preferred Mask
Preferred Mask refers to a type of existing medical mask used for PAP therapy.
Nuance Pro
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
autoPAP
autoPAP
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.
autoPAP
autoPAP
TAP PAP
TAP PAP
Interventions
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Nuance Pro
Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
autoPAP
autoPAP
TAP PAP
TAP PAP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Partial Response to oral appliance therapy: AHI \> 5
Exclusion Criteria
* Pregnancy
* Edentulous
* Prisoners
18 Years
ALL
Yes
Sponsors
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Joseph Adame
INDIV
Responsible Party
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Joseph Adame
J. Michael Adame, DDS, Principal Investigator
Locations
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J. Michael Adame, DDS, PA
Edinburg, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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20170991
Identifier Type: -
Identifier Source: org_study_id
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