The success of FaceFormer therapy in patients with snoring and sleep apnoea was to be assessed in a controlled study (pilot study). A daily therapy of 4 exercise units was required for a three-month phase. Each exercise unit comprised 20 repetitions of the basic exercise and 20 repetitions of at least one pulling exercise. After approx. 3 weeks, when a training-related improvement in nasal breathing was noticeable, the FaceFormer was also used at night. The aim was to acclimatize nasal breathing.

Effect of FaceFormer® therapy for snoring and sleep apnea

Investigation period

March 25 2002 – January 30 2003

Examination intervals

6 examination appointments

Initial examination, then 4x after 3 weeks, 1x after a further 3 months

Test subjects

At the beginning of the examination 38 subjects. Only 30 test subjects who took part in 6 check-up appointments and regularly recorded their exercise progress on a form were evaluated.

N = 30

Selected patients: Diagnosed sleep apnoea syndrome

RDI > 18, regardless of gender, 8 f, 22 m

The body mass index was determined during the initial examination.

Age of the test persons

Age of the test persons

N = 30

Age values

Age values
N = 30

Body-Mass-Index (BMI)

N = 30
Max = 39
Min = 19

Investigation procedure

Patients were selected for whom polysomnographic examination results were available from sleep laboratories or outpatient examinations. The data were selected as the baseline values for the study. All diagnoses were made no more than 6 months previously. Patients were guaranteed not to be using any other treatments during FaceFormer therapy. Some patients who were treated with NCPAP or BIPAP did not or no longer used the devices due to a lack of acceptance. None of the participants had ever undergone surgery for snoring.

At the follow-up appointments, the patients entered their assessments of changes in sleep, daytime sleepiness, vigilance and effects on general well-being on a rating scale of 1-10. 1 corresponded to the worst rating, 10 to the best.

Lip strength measurements were taken with the ISST myo-bar meter at all appointments and recorded as diagnostic data. It was assumed that improved lip strength would increase the likelihood of mouth closure during sleep phases and that nasal breathing would be habituated through night-time mouth closure.

After 12 weeks, all patients took part in an outpatient polysomnographic examination. These were repeated after a further 3 months (in total from the start of therapy after 6 months). The results were used as final data for the study.

Nocturnal snoring episodes

Before the therapy, all test subjects had clear snoring episodes.

No snoring (level 1)
before: 0 participants
after: 16 participants

Division into 4 levels

N = 30
Value 1 = none
Value 2 = slight
Value 3 = increased
Value 4 = significantly increased

Number of nocturnal snoring episodes before and after therapy

Respiratory Disease Indizes (RDI)

RDI before and after therapy

N = 30
RDI before therapy = 18-25
RDI after therapy = 1-14

RDI development

RDI: Entwicklung innerhalb von 12 Wochen

Development of the RDI within 12 weeks

N = 30

Relative development of RDI

RDI development within 12 weeks in percent in relation to

N = 30
Average improvement = 70.81%
Slightest improvement = 50%
Greatest improvement = 88.89%

Duration of nocturnal breathing interruptions in seconds

Dauer der nächtlichen Atemaussetzer in Sekunden

Breathing stops in seconds

N = 30
before therapy = 8-48
after therapy = 1-14

Average oxygen value during the sleep phase

Average oxygen supply
before and after therapy

N = 30
before therapy = 71-99
after therapy = 89-99

Lip force measurement with ISST-Myo-Bar-Meter

Lippenkraftmessung mit ISST-Myo-Bar-Meter

Lip strength before and after therapy

N = 30
vor Therapie = 18-35 mBar
nach Therapie = 45-68 mBar

When measuring lip force, none of the participants reached the minimum standard value of 36 mBar at the beginning of the study. At the end of the study, all were well above this. No participant was below 45 mBar.