Evaluation of the effect of positional therapy with the SPT Wave on sleep apnea severity, i.e. re-duction of the apnea-hypopnea index (AHI).
ID
Source
Brief title
Condition
- Other condition
- Upper respiratory tract disorders (excl infections)
Synonym
Health condition
Obstructief Slaap Apneu Syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI,
reduction of % of sleeping supine sleep position of the head, without
disturbance of the sleep quality.
Secondary outcome
Secondary endpoints: Outcome of Quality of Life questionnaires; Epworth
Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ),
Subjective Treatment Satisfaction Questionnaire (STSQ) . Compliance and
learning effect will also be evaluated after 50 days usage.
Demographic parameters: Sex, age, length, weight, BMI, alcohol intake,
medication will also be noted.
Background summary
Fifty-six percent of patients with Obstructive Sleep Apnea (OSA) are position
dependent,
defined as having an Apnea hypopnea index (AHI), which is at least twice as
high in supine sleeping position compared to the AHI during sleep in other
positions. Standard therapy for patients with mild or moderate positional OSA
(POSA) is treatment with an Oral Appliance Trainer (OAT) or surgery. Recently
the Sleep Position Trainer (SPT) has been studied for patients with POSA. In
this research a new device that uses auditory stimulation, the SPT Wave, will
be introduced for patients with POSA.
Study objective
Evaluation of the effect of positional therapy with the SPT Wave on sleep apnea
severity, i.e. re-duction of the apnea-hypopnea index (AHI).
Study design
Multicentre clinical trial
Intervention
A new product for head positional therapy, the SPT Wave, has been developed
based on the same working principle of the Sleep Position Trainer but now
focusing specifically on head positional therapy. The SPT Wave is placed on the
temporal bone, lateral from the eyes. It measures the head sleeping position
and gives the patient auditory stimulation feedback when the patient*s head is
in the supine position. The patient is then able to react to the auditory
signal and turn the head or head and trunk into a non-supine position. The PSG
with the SPT Wave will be repeated after 50 days of usage and the results will
be compared with the baseline PSG.
Study burden and risks
The risks for patients participating in this study are negligible.
Inconveniences of the SPT Wave can be discomfort caused by irritation of the
band, difficulties with an increased sleeping period with the head in
non-supine sleeping position or difficulties sleeping with the SPT Wave, as
well as possible irritation in the ear canal or from the sound. This can be
compensated by the expected improvement of sleep quality caused by the therapy.
Molengraaffsingel 12-14
Delft 2629 JD
NL
Molengraaffsingel 12-14
Delft 2629 JD
NL
Listed location countries
Age
Inclusion criteria
+ 18 years and older.
+ Ability to speak, read and write the local country*s language (Dutch, French or Spanish depending on the country).
+ Ability to follow up.
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Diagnosis of 10 to 90% head supine position during the night.
+ AHI head supine is 2 > as high as AHI non-supine.
+ AHI head and trunk supine is 2 > as high as AHI non-supine.
+ Own a Windows PC and ability to install SPT connection software and upload research data.
+ Expected motivation to wear the SPT Wave for 50 days.
+ Expected to maintain current lifestyle (sports, medicine, diet etc.).
+ Normal audiogram for both ears
Exclusion criteria
- Central Sleep Apnea Syndrome.
- Night or shifting work.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Hearing loss, wearing other ear devices.
- Anatomic ear abnormalities which influences correct attachment of the SPT Wave to the head and ear
- BMI above 35
- Extreme Migraine
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL44820.029.13 |