sleepingdisorder with apnoeas
Conditions
Interventions
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 the
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: + Diagnosis with symptomatic mild or moderate OSA (5 2 times as high as AHI non-supine.
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed