Original Cohort Clinical Study
Location: Essen, Germany and Nottingham, UK
Cohort: 19 male and 8 female patients aged 25 to 68, 8 primary snorers (AHI<5) and 19 mild OSA (AHI 5-15), Average BMI 29.7
82% of Bed Partners reported snoring reduction of an average of 40%
The original clinical trial with Snoozeal® was a prospective multi-centre trial of individuals with snoring and/or mild OSA (AHI <15) led by Professor Boris Stuck.
Snoring was assessed using a bed partner reported visual analogue scale (VAS) (range 1-10, 10 = unbearable snoring). The snorers’ sleep quality was recorded using the Pittsburgh Sleep Quality Index (PSQI).
To minimise night-to-night variation in reported VAS, recordings over a 2-week period were averaged and compared: pre-treatment (2-weeks before the start of therapy), during treatment phase (last 2-weeks of 6-week therapy period) and post-treatment (2-weeks after stopping therapy).
The therapy was a 6-week daytime treatment period of intraoral tongue stimulation with the Snoozeal® device for one 20-minute treatment a day.
The mean bed partner reporting snoring score reduced by 52% from 6.4 to 3.1 (p=0.001) with over 80% declaring a reduction of >40% in the reported snoring.
The change remained statistically significant for Primary Snorers (VAS reduction of 6.4 to 2.7, p=0.001) and Mild OSA patients (VAS reduction 6.6 to 3.6, p=0.001).
The VAS remained stable for the 2-weeks after stopping the therapy (mean VAS 3.3) suggesting a sustained change in muscle physiology.
There was also a statistically significant improvement in 3 of 8 components of the PSQI (Sleep Quality, Sleep Disturbance and GlobalScore), supporting a concurrent improvement in the snorer’s sleep quality with the use of the device.