To evaluate the effect and cost-utility of positional therapy, comparing the SPT and MRA versus CPAP in patients with moderate positional obstructive sleep apnea.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary ouctome: AHI
Secondary outcome
1) Outcome of Quality of Life questionnaires; EQ-5D, ESS and FOSQ.
2) (Societal) costs of treatment; Healthcare Consumption, Illness and Work
(HCIW) questionnaire (PCQ/MCQ, successors of TiC-P and PRODISQ).
3) Compliance, i.e. more than 4 hours of usage per night.
4) Cardiovascular parameters: blood pressure, pulse rate, BMI and neck
circumference
Background summary
Around 2-4% of the western population suffers from Obstructive Sleep Apnea
Syndrome (OSA). OSA is more common in males than in females, with a ratio of
2:1 and the prevalence increases in midlife. According to the LAN publication
the prevalence in The Netherlands is estimated to be between 315.000 and
500.000 patients.Fifty-six percent 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 moderate POSA is treatment with an Oral
Appliance Trainer (OAT) or continuous positive airway pressure (CPAP) .
Recently a new device Sleep Position Trainer (SPT) is been introduced
especially for patients with POSA.
Study objective
To evaluate the effect and cost-utility of positional therapy, comparing the
SPT and MRA versus CPAP in patients with moderate positional obstructive sleep
apnea.
Study design
A multicenter RCT will be performed with a follow-up of 12 months per patient.
Patients will be randomized for MRA combined with SPT versus CPAP. All outcomes
will be measured at baseline, month 3, 6 and 12.
Intervention
The SPT trains POSA patients to sleep in non-supine positions, CPAP uses
positive airway pressure to open the airway; MRA is an intra-oral prosthesis,
which holds the mandible in a protrusive position, all to prevent effectively
apneic events.
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. Side
effects due to CPAP include nasal congestion, rhinorrhea, epistaxis, dryness of
the mouth and nose, aerophagia. Other problems reported include mask
discomfort, mask leakage, claustrophobia, inconvenience of being connected to a
machine, difficulty in falling asleep, frequent nocturnal awakenings, lack of
symptomatic benefit, intolerance of high expiratory pressure, and noise of the
device. Withdrawing from this therapy means immediate relief of inconveniences.
Jan Tooroprstraat 164
Amsterdam 1061 AE
NL
Jan Tooroprstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis with symptomatic mild or moderate OSA (15 < AHI < 30).
- Diagnosis of 10 to 90% supine position during the night.
- AHI supine is 2 > as high as AHI non-supine.
Exclusion criteria
- Many dental problems; insufficient teeth for wearing MRA
- Medication used/ related to sleeping disorders
- Central Sleep Apnea 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.
- 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 with MRA, CPAP or SPT
- 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 | NL52032.029.15 |