Prospective Clinical Study at London University Institution

Location: A London University Institution
Clinical Study Lead: Prof. Bhik Kotecha
ClinicalTrials.gov identifier: NCT03829956
Cohort: 115 patients (73 men and 42 women) aged 24 to 79, with a BMI range of 20 to 34. 50 were primary snorers (AHI<5) and 65 had mild OSA (AHI 5 – 15).
Documents: View Original Paper

79% of sleep apnea patients achieved a reduction in sleep apnea measures.

Overview

The aim was to use validated objective measures and assess the reproducibility of the subjective outcomes of the previous study at further independent facilities. This was a prospective cohort study on individuals with Mild OSA and/or Primary Snoring (AHI <15).

The study was based on Home sleep studies (WatchPAT®) to access objective snoring (% time snoring) and respiratory parameters (AHI, ODI, Saturations) with two consecutive night sleep studies before and two consecutive night sleep studies after the use of the device.

This was supplemented with bed partner VAS ratings of snoring and sleep quality questionnaires – Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI).

The eXciteOSA® device was used for 20-minutes, once a day for a 6-week period.

Objective improvement in mild OSA

AVERAGE % REDUCTION IN AHI, ODI, AND ESS IN PATIENTS WITH MILD OSA PRE AND POST-THERAPY WITH EXCITEOSA®

AVERAGE OF 52% REDUCTION IN AHI

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AVERAGE OF 50% REDUCTION IN ODI

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AVERAGE OF 3.9 POINT REDUCTION IN ESS

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p=0.001

Objective improvement in snoring.

AVERAGE % REDUCTION IN SNORING TIME AND BED PARTNER REPORTED (VAS) IN PATIENTS PRE- AND POST -THERAPY WITH eXciteOSA®

Objective Snoring >40dB

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Objective Snoring >45dB

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Objective Snoring >50dB

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SUBJECTIVE SNORING

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90% of patients reported a reduction in snoring time

89% of bed partners reported a reduction of their partners snoring

79% of sleep apnea patients achieved a reduction in sleep apnea measures