The aim of this study is to evaluate the PAP treatment response in OSA patients during the first three weeks by monitoring the relevant objective and subjective sleep parameters.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
slaapstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient demographics and medical information, treatment information (e.g., PAP
readout), wearable-derived sleep parameters
Secondary outcome
Ambulatory PSG/PG/Watchpad-derived parameter, digital sleep diary,
questionnaires
Background summary
The most common treatment for OSA patients is positive airway pressure (PAP).
Most assessments of PAP-treatment are restricted to polysomnnography
measurement of a single night in the laboratory or sometimes at home. However,
it has been shown that many sleep parameters show a high night-to-night
variability. Therefore, a single-night measurement is likely not representative
of the patients regular sleeping patterns. Multi-night monitoring is needed to
overcome the limitations of previous research, to assess the night-to-night
variability of various sleep parameters and to assess the treatment response
more effectively. Recent advancements in wearable sensor technology have opened
up new opportunities to unobtrusively measure sleep for multiple nights in the
patient*s home.
Study objective
The aim of this study is to evaluate the PAP treatment response in OSA patients
during the first three weeks by monitoring the relevant objective and
subjective sleep parameters.
Study design
This is a prospective observational study in patients who are diagnosed with
OSA at Maxima Medical Center and will be receiving PAP treatment for the first
time. Participants in this study will receive routine clinical care.
Additionally, they will receive three additional measurements as part of this
study: A wearable sensor, a digital sleep diary, and several questionnaires.
The participants are asked to wear the wearable sensor during the night and to
complete the digital sleep diary questions during the first three weeks of PAP
treatment. In addition, the participants are three times asked to fill in
several questionnaires: After one day, three and 14 weeks of PAP-treatment.
Study burden and risks
There are minimal risks for participants in this study. Participants may
sometimes experience skin irritation when wearing the sensor (for too long) or
may experience discomfort due to wearing the sensor during the night. This risk
is acceptable, and the chance of this occurring is small. The wearable sensor
is CE marked and extensively tested. In addition, the participants can take off
the wearable sensor in case it causes skin irritation.
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
• Age older than 18
• Diagnosis of OSA
• Speaking and reading Dutch
• Written informed consent
• PAP treatment is prescribed for the first time
• Attend a PAP-initiation meeting
• PSG, PG or WatchPAT recording available
• Online intake questionnaire available
Exclusion criteria
• Suspicion of complex comorbid (sleep)disorders (as indicated by the clinical
sleep expert).
• (Suspicion of) underlying severe neurological or psychiatric disorders,
presence of persistent heart rhythm disorders, presence of autonomic
dysfunction.
• Known allergies for hard plastic (like in sport watches) or wristband material
• Presence of wounds, injuries, or inflammation on the skin where the wristband
will be placed
• Tattoo on top of the wrist or head (where the sensor should be placed)
• Pregnancy
• Working in (rotating) night shifts
• Inability to adhere to the study protocol
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 | NL87242.015.24 |