Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/ endpoints: Primary endpoints; reduction of PSG
parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine
sleep position, without disturbance of the sleep quality.
Secondary outcome
Secondary endpoints: Outcome of Quality of Life questionnaires; ESS, FOSQ,
OHIP-14 and MFIQ. Compliance and learning effect will also be evaluated in 3
and 12 months. Finally the cardiovascular parameters like blood pressure, pulse
rate and BMI/neck circumference will be assessed.
Background summary
Rationale: 56% of patients with Obstructive Sleep Apnea (OSA) are position
dependent, defined as having an 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 having mild or moderate POSA is treatment with an
Oral Appliance Trainer (OAT). Recently a new device Sleep Position Trainer
(SPT) is been introduced especially for patients with POSA.
Study objective
Objective: To compare the effect of positional therapy with the SPT versus OAT
on polysomnographic (PSG) parameters, to evaluate the compliance and measuring
the possible learning effect that might occur with POSA patients using the SPT
for positional therapy over a long term.
Study design
Study design: Randomised controlled trial
Intervention
Intervention: The SPT is a sensor positioned in an elastic band attached around
the body. The SPT measures the body position and vibrates when the patient lies
in supine position. Oral appliance therapy (OAT) is an intra-oral prosthesis,
which holds the mandible in a protrusive position. Because of this position
more pharyngeal space will be available and the AHI will decrease.
After randomisation the first group (n=38) will sleep for a period of 90 +/- 2
days with the SPT every night. The second group (n=38) will also sleep for a
period of 90 +/- 2 days only with MRA. After this period the PSG is repeated.
Long-term outcome in AHI is measured by repeating the PSG after 1 year.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The risks for patients participating in this
study are negligible. Inconveniences of the SPT can be discomfort caused by
irritation of the band, difficulties with an increased sleeping period on the
side or difficulties sleeping with the SPT. This can be compensated by the
expected improvement of sleep quality caused by the therapy. Short term side
effects of OAT may be discomfort in the jaw and dry mouth. Whereas in long term
usage changes in the jaw can cause pain and sensitivity of the teeth.
Withdrawing from this therapy means immediate relief of inconveniences.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Diagnosis of 10 to 90% supine position during the night.
+ AHI supine is >2 times as high as AHI non-supine.
Exclusion criteria
- Many dental problems; insufficient teeth for wearing MRA.
- Medication used/ related to sleeping disorders
- Central Sleep Apnoea Syndrome.
- Night or shifting work.
- Severe chronic heart failure.
- 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.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not
compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA
- Pregnancy
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 | NL41516.018.12 |