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The aim of this study is to see if the Snoozeal device is as effective as the previous methods and if it can reduce snoring and improve sleep quality.
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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Upper respiratory tract disorders (excl infections)
Study type
Observational non invasive
ID
NL-OMON55000
Source
ToetsingOnline
Brief title
eXciteOSA study (Snoozeal)
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
apnea, Snoring
Research involving
Human
Sponsors and support
Primary sponsor :
Signifier Medical Technologies
Source(s) of monetary or material Support :
Signifier Medical Technologies
Intervention
Keyword :
Daytime, Mild obstructive sleep apnea, Neuromuscular stimulation, Snorring
Outcome measures
Primary outcome
Primary Objective
1) To assess the efficacy of daytime trans-oral neuromuscular stimulation
training on respiratory indices of Sleep disordered breathing
Change in AHI and ODI (Comparison of pre and post therapy sleep studies)
2) To assess the efficacy of daytime trans-oral neuromuscular stimulation
training on objective snoring in Sleep disordered breathing
Change in Objective snoring pre and post therapy (% snoring at 40, 45 and 50dB)
Secondary outcome
Secondary Objectives
1) To assess the efficacy of daytime trans-oral neuromuscular stimulation
training on snoring sleep quality.
Comparison of sleep quality questionnaires at start and end of therapy (PSQI,
ESS, EQ-5D-5L)
2) To assess the efficacy of daytime trans-oral neuromuscular stimulation
training on snoring reported by sleep partner
Comparison of visual analogue scale of snoring reported by partner
Background summary
It has been shown that a common cause for snoring and throat obstruction
(obstructive sleep apnoea) is excessive loss of muscle tone in the throat when
we go to sleep. This results in the partial collapse of the throat (snoring) or
complete collapse (obstructive sleep apnoea) during sleep.
45% of the male population snore. Sleep apnoea affects 4 to 6% of the
population and is associated with increased incidence of raised blood pressure,
heart attacks and strokes. Although there are several lifestyle practices
associated with snoring such as smoking, obesity and drinking, a significant
proportion of people may snore despite not being associated with these.
A solution to this issue is to improve the muscle tone of the throat so that it
doesn*t collapse so easily. Several studies have shown that certain types of
throat exercises can help reduce snoring. Further studies have also shown that
using electrical stimulation to exercise the tongue muscles has the same
effect.
From this, doctors in the UK have developed a new type of device, Snoozeal,
that allows a more accurate and comfortable way of delivering this energy to
exercise the tongue muscles. The device works by stimulating the tongue muscles
during the day so that the tongue is less likely to collapse during sleep. It
is a form of *workout* for the tongue and like other physical exercise regimes,
it needs to be repeated regularly for a few weeks to take effect.
Study objective
The aim of this study is to see if the Snoozeal device is as effective as the
previous methods and if it can reduce snoring and improve sleep quality.
Study design
Multi centre, observational, prospective, post market surveillance study
Intervention
Intra-oral neuromuscular stimulation training with a a device using 20 minutes
during daytime
Study burden and risks
not applicalble
Public
Signifier Medical Technologies
Hammersmith Grove 5-17
london W6 0LG
GB
Scientific
Signifier Medical Technologies
Hammersmith Grove 5-17
london W6 0LG
GB
Listed location countries
Netherlands
Age
Adults (18-64 years)
Elderly (65 years and older)
Inclusion criteria
Participant is willing and able to give informed consent for participation in
the trial
Male or female, aged 18 years or above
AHI 5-15/hr as confirmed by polysomnography
Bedpartner
Exclusion criteria
* BMI >35 kg/m2
* 5< AHI >15/h, i.e. evidence of moderate to severe OSA from polysomnography
* Symptomatic nasal pathology i.e. septal deviation, nasal polyposis or chronic
rhinosinusitis
* Tonsil Hypertrophy (Tonsil size * Grade 3 or greater)
* Tongue or lip piercing
* Pacemaker or implanted medical electrical devices
Pregnancy or planned pregnancy (device has not been tested or approved for use
in pregnant women)
* Previous oral surgery for snoring
* Relevant facial skeletal abnormalities (i.e. syndromic facial deficiencies,
severe micrognathia etc.)
* Any criteria that, in the opinion of the investigator, would make the
participant unsuitable for the study due to inability to complete required
study procedures
Design
Study phase :
4
Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
16
Type :
Actual
Medical products/devices used
Generic name :
intra-oral neuromuscular stimulation device (eXiteOSA)
Registration
:
Yes - CE intended use
Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04392765 |
| CCMO | NL73741.100.20 |
