Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorThomas Jefferson University

About this trial

To date, there has been no head to head comparison of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) utilizing a full night polysomnographic evaluation. With this study we aim to evaluate a pilot cohort of patients with OSA treated with CPAP or UAS using the WatchPAT polysomnography system.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than 22 years old

History of moderate to severe OSA (AHI 15-65)

UAS implantation with postoperative titration and demonstrated successful use of therapy or has demonstrated the ability to tolerate CPAP for greater than 4 hours per night 5 days per week.

Disqualifiers

none

Trial population

Patients using upper airway stimulation or continuous positive airway pressure

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: Upper airway stimulation
Group B: Continuous positive airway pressure

Trial outcomes

Primary outcomes

1

Difference in polysomnography (PSG) data between UAS and CPAP groups

Time frame
2 years
2

Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups

Time frame
2 years
3

Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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