Primary Objective: Assess which digital health metrics are relevant to monitor for patients with (or highly suspected of having) obstructive sleep apnea before and after diagnosis, and during titration of treatment with continuous positive airway…
ID
Source
Brief title
Condition
- Other condition
- Upper respiratory tract disorders (excl infections)
Synonym
Health condition
Obstructieve slaapapneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints
Digital health metrics and EMA items
The quantitative assessment will statistically explore the relationship between
digital OSA-related health metrics that are continuously collected using
sensor-based digital health technologies with subjective data that is collected
via a short EMA questionnaire that is administered each morning . As such, the
subjective morning EMA data can be seen as the study*s primary endpoint,
whereas the objective nocturnal digital health data are the key study
parameters of interest that may be related to the subjective data.
Exit survey and interviews
Study participants will fill out a survey about meaningfulness of assessed
digital health parameters based on the personal health data report that they
receive at the end of study (survey is included as attachment). Additionally, a
representative sample of participants is invited for a semi-structured
interview to establish meaningfulness and actionability of each health
parameter in the patient data report, that they receive after the final night
of measurements (interview guide is included as attachment).
Secondary outcome
Secondary endpoints
PROM
The Quebec Sleep Questionnaire (QSQ) is a 32-item scale that evaluates the
impact of OSA over the past 4 weeks in five different domains, namely
hypersomnolence, daytime symptoms, nighttime symptoms, emotions, and social
interaction. The QSQ will be taken at study onset, at the start of the
patient*s treatment and 1 and 2 months after treatment initiation.
These data will be used to at least (1) describe the patient sample to aid the
interpretation of the generalizability of the current study using T0 QSQ data,
as well as potentially (2) describe the patients* complaints in the descriptive
secondary endpoint, (3) help predict the PG-related OSA diagnosis outcomes in
the related secondary objective using T0 QSQ data, and (4) explore to what
degree the trends in the daily EMA items and/or daily OSA-related digital
health metrics relate to QSQ outcomes.
Background summary
Obstructive Sleep Apnea (OSA) is a common chronic sleep breathing disorder
characterized by intermittent breath stops leading to hypoxemia and reduced
sleep quality (Lv et al., 2023).Untreated OSA is associated with increased risk
for adverse cardiac outcomes (Lv et al., 2023). OSA is diagnosed through a
single-night sleep study and most frequently prescribed treatments are
continuous positive airway pressure (CPAP) and mandibular advancement device
(MAD) (Heijn Van Mechelen et al., 2021; Luong et al., 2024). Currently,
objective data collection is limited to a single-night sleep study at diagnosis
and a few metrics returned by machines used for continuous positive airway
pressure (CPAP) therapy during use. MAD treatment outcome assessments are based
on subjective report of symptoms. A previous study including a survey and
interviews with individuals with OSA revealed a strong need for objective OSA
monitoring. Sensor-based digital health technologies offer the opportunity to
objectively and longitudinally assess OSA health metrics, enhancing diagnostic
accuracy, facilitating more effective treatment titration, and improving
self-management abilities.
Study objective
Primary Objective:
Assess which digital health metrics are relevant to monitor for patients with
(or highly suspected of having) obstructive sleep apnea before and after
diagnosis, and during titration of treatment with continuous positive airway
pressure (CPAP) or mandibular advancement device (MAD) in the Netherlands.
Secondary Objective(s):
• Explore longitudinal trends in digital OSA-related health metrics within the
context of Quebec Sleep Questionnaire (QSQ, Patient-reported outcome measure)
during the first 2 months of CPAP or MAD treatment.
• Explore if polygraphy (PG) based OSA diagnosis can be predicted using digital
OSA-related health metrics and QSQ. Assess which digital health metrics are
relevant to monitor for patients with (or highly suspected of having)
obstructive sleep apnea before and after diagnosis, and during titration of
treatment with continuous positive airway pressure (CPAP) or mandibular
advancement device (MAD) in the Netherlands.
Study design
Prospective single-center observational longitudinal mixed-method study.
Study burden and risks
Burden
The total burden for the participant during the study consists of 2 visits to
ZMC to collect devices and receive instructions at start of study and return
devices at the end of study. Since this will be combined with installation of
PG/PSG devices following standard of care, this does not require extra clinic
visits. Devices will be returned to ZMC at end of study together with PSG/PG
devices. During the observational phase, participants will need to wear the
Corsano cardio watch 24/7, but can follow their usual lifestyle. Potential
risks include allergic reactions to the bracelet, which is made of fabric.
Filling out short daily questionnaires (max 5 mins), 4 times a long
questionnaire (max 15 mins) and finally an exit survey (max 10 minutes) and for
10-15 participants a 45 min interview is the required time investment of
participants.
Benefits
Participants will receive a comprehensive report with their personal health
metrics collected before and after treatment initiation. Based on insights from
a survey and interviews with OSA patients done in previous projects, we suspect
that these data will be highly valued by the participating patients as it will
provide objective insights into treatment outcomes that may contribute to
enhanced self-management abilities and shared clinical decision making.
Sylviusweg 71 71
Leiden 2333 BE
NL
Sylviusweg 71 71
Leiden 2333 BE
NL
Listed location countries
Age
Inclusion criteria
• Clinically relevant symptoms, at physician*s discretion.
o Reduced emotional wellbeing
• High OSA risk based on STOP-BANG questionnaire
• >=18 years old
• In possession of a Smartphone running on a recent version of iOS or Android
• Proficient in the Dutch language, enabling them to understand and complete
questionnaires without assistance.
Exclusion criteria
• (Night) shift workers
• 4 or more alcoholic drinks per day on a regular basis or use of recreational
drugs
Following conditions might not return reliable digital OSA data, as the
Withings Sleep Analyzer algorithm is not trained or tested in these contexts.
Therefore (suspicion) of below conditions are listed as exclusion criteria:
• Presence of acute or severe chronic respiratory muscle weakness due to
neuromuscular condition
• Awake hypoventilation
• Suspicion of sleep-related hypoventilation
• Chronic opiod medication
Design
Recruitment
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 | NL88687.028.25 |