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

Joseph Adame

Status: Completed

Conditions: Treatment for Obstructive Sleep Apnea

Treatments: Device: TAP PAP; Device: Nuance Pro; Device: autoPAP

Study type: Interventional

Identifiers

NCT04029311

20170991

Details and patient eligibility

About

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:

2. Apnea Hypopnea Index (AHI) reduction

3. Amount of side effects

4. Amount of Leaks

5. Hours of use (compliance)

6. CPAP pressure

7. There is a difference between connected and disconnected for the following symptoms:

8. Epworth sleepiness Scale (ESS)

9. Functional Outcomes of Sleep Questionnaire (FOSQ)

10. Side effects Study Design - randomized prospective parallel

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Combination Therapy with Preferred Mask

Experimental group

Description:

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

Treatment:

Device: Nuance Pro

Device: autoPAP

Combination Therapy with Custom Mask

Experimental group

Description:

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

Treatment:

Device: TAP PAP

Device: autoPAP