sleep position device can be used to treat positional obstructive mild to moderate central sleep apnea syndrome.1-5 Efficacy in positional central sleep apnea syndrome is unkown. Apnea is positional in 56% of the cases, meaning the events do not…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
centraal slaap apneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters
AHI at 3 months and at 12 months will be compared to baseline using students
t-test. Succesfull treatment is defined as a reduction in AHI to < 5 events
per hour at 3 months. Or either a 50% reduction in baseline AHI or a >= 10
decrease in AHI combined with improvement in ESS (>= 2 points) .20,21 The
proportion of patients reaching succesfull treatment in both treatment arms
will be compared using Chi square test.
Secondary outcome
Secondary study parameter(s)
total central AI, total central AHI, AHI supine , AHI non supine, supine
central AHI, non-supine central AHI, ESS, total sleep time supine, total sleep
time non-supine will respectively be compared to baseline at resepectively 3
months and 12 months using student t-test.
Other study parameters
General baseline measurements: age, sex, weight, height, BMI, active
smoking yes/no will be compared between treatment arms using student t-test
for continuous parameters and Fisher's Exact test for categorical variables.
Background summary
Sleep Position Device Versus Continuous Positive Airway Pressure in Mild to
Moderate Central Sleep Apnea
A Randomized Trial
A sleep positional device can be used to treat positionally obstructive mild to
moderate central sleep apnea syndrome.1-5 Efficacy in positional central sleep
apnea syndrome is unknown. Apnea is positional in 56% of the cases, which means
that the events do not occur when you sleep on the side. NightBalance developed
a sleeping place device for these patients. The small lightweight device is
worn in a belt around the chest, reminding the patient with gentle vibrations
not to sleep on their backs. These soft vibrations do not disturb the sleep
quality. It is a small device and is worn at the front of the body in a
comfortable, adjustable chest strap. It has smart algorithms that automatically
adjust the vibration strength to each individual, and intelligent patterns that
avoid habituation and result in long-term compliance.
CPAP is standard treatment in the central sleep apnea syndrome.6-11 The CPAP is
a small box with a motorized fan in it. This fan draws in air from the chamber,
pressurizes it gently and then delivers it to a pressure setting specifically
tailored to the needs of the patient. The air inlet segment of a CPAP machine
has a filter to eliminate the absorption of dust, smoke or other impurities in
the air. The CPAP machine has a humidification chamber built into the box.
Water is heated here to moisten the compressed air before it is delivered. A
hose is attached to the CPAP machine that connects the box to a CPAP mask. The
CPAP mask and CPAP machine settings are made on the patient during a clinical
CPAP start night at the hospital sleep center.
Study objective
sleep position device can be used to treat positional obstructive mild to
moderate central sleep apnea syndrome.1-5 Efficacy in positional central sleep
apnea syndrome is unkown. Apnea is positional in 56% of the cases, meaning the
events do not occur when sleeping on the side. For these patients NightBalance
developed a sleep position device. The small lightweight device is worn in a
belt around the chest, reminding the patient with gentle vibrations to not
sleep on their back. These gentle vibrations do not disrupt sleep quality. It
is a small device, and is worn on the front side of the body in a comfortable,
adjustable, chest band. It has smart algorithms that automatically adjust the
vibration strength to each individual, and intelligent patterns that avoid
habituation and result in long term compliance.
CPAP is standard of care treatment in central sleep apnea syndrome.6-11 The
CPAP is a small box which has a motorized fan inside. This fan draws air from
the room, gently pressurizes it, then delivers it at a pressure setting
specific to the needs of the patient. The air intake section of a CPAP machine
has a filter on it to eliminate the intake of dust, smoke, or other impurities
in the air. The CPAP machine has a humidification chamber built into the box.
This is where water is warmed to humidify the pressurized air before it is
delivered. Attached to the CPAP machine is a hose which connects the box to a
CPAP mask. The CPAP mask and CPAP machine settings are fitted to the patient
during a clinical CPAP start night at the sleep centre in our hospital.
Study design
Epworth Sleepiness Scale (ESS) wordt gemeten bij aanvang en vervolgens onder
behandeling op 3 en 12 maanden. Polysomnografie voor AHI-meting wordt herhaald
onder behandeling na 3 en 12 maanden.
Study design: A single-centre randomised prospective trial between CPAP and
sleep position device treatment. Randomisation was stratified according to BMI
and smoking. Physician and patients are not blinded to the treatment arms.
Written patient informed consent is obtained. Diagnosis at baseline is by
polysomnography. Eligible patients are randomized to either standard CPAP
therapy or SPD treatment.
Epworth Sleepiness Scale (ESS) is measured at baseline and subsequently under
treatment at 3 and 12 months. Polysomnography for AHI measurement is repeated
under treatment at 3 and 12 months.
Study burden and risks
no risk, low burden, at the follow-u[ after 3 and 12 months an extra
polysomnography is performed.
Van Swietenlaan 1
Groningen 9728 NT
NL
Van Swietenlaan 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
1. Patients with central positional sleep apnoea are included in the study.
2. Apnoehypopneuindex >= 5 AND <= 30.
3. Patient age >= 18.
Exclusion criteria
1. chronic respiratory insufficiency (paCO2 > 6kPA)
2. BMI >= 30
3. Left sided valvular heart disease > mild
4. Patients with symptomatic heartfailure (AHA stadium C)
5. Night or rotating shift work
6. Active psychiatric disease
7. Seizure disorder
8. Medication use for sleeping disorders
9. Previous treatment with CPAP or sleep position device
10. Simultaneous other OSAS treatments
11. Pregnancy
12. Coexistent non-respiratory sleep disorders (e.g. insomnia, periodic limb
movement disorder, narcolepsy) that would influence functional sleep assessment
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL70711.099.19 |
| Other | volgt |
| OMON | NL-OMON20065 |