The aim of this proof-of-concept study is to analyze the use of heart rate based variables using the Apple Watch:A) To predict Acute Chest Syndrome in patients hospitalized patients for painful crises;B) To predict painful crises in ambulant…
ID
Source
Brief title
Condition
- Haemoglobinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
- Heart related variables: resting heart rate, heartrate/steps-ratio
- Variables of Heart Rate variability (e.g. Standard deviation of the R-R
intervals = SDNN, RMDD, HF, LF/HF-ratio)
Primary oucomes:
A: Occurrence of Acute Chest Syndrome
B: Self-reported painful crises
Secondary outcome
• Length of stay (LOS)
• Need of (P)ICU admission
• Need of red blood cell transfusion
• Need of analgesic or opioids: maximum dose during hospital admission
Background summary
Sickle cell disease (SCD) is the most common inherited red blood cell disorder.
It is characterized by polymerization of hemoglobin S, resulting in the
formation of rigid sickled-shaped red blood cells.
These cells can occlude the microvasculature causing hemolytic anemia,
irreversible-organ damage and recurrent painful vaso-occlusive crises.
In its severe form, these crises require hospitalization for administration of
intravenous opioids. When patients are hospitalized for a painful crises, some
may develop severe respiratory complications, called Acute Chest Syndrome
(ACS). The clinical presentation of SCD is highly variable among patients and
there are no adequate (bio)markers available. For this reason, this study is
focused on the early prediction of ACS in admitted patients and the prediction
of painful crises in ambulant patients. For the prediction, we will measure
heart rate based variables (including heart rate variability) using the Apple
Watch.
Study objective
The aim of this proof-of-concept study is to analyze the use of heart rate
based variables using the Apple Watch:
A) To predict Acute Chest Syndrome in patients hospitalized patients for
painful crises;
B) To predict painful crises in ambulant patients.
Study design
Patients with SCD from the age of 16 years old will be included in this study,
divided over two study groups:
A) Hospitalized patients with painful crisis, longitudinal measurements
B) Ambulant patients, longitudinal measurements
Study burden and risks
The burden and the risks associated with participation in this study are low.
Subjects will be asked to wear a wearable device on the wrist during the study
period.
The additional burden for study participants in part B (ambulant patients to
predict painful crises) is to keep a pain diary for the duration of six months.
The study is group-related, because SCD has a highly variable phenotype
between patients and even within the same genotype. The variation is even
greater if age is taken into account; children and adults are physiologically
and pathophysiologically different from each other. Results obtained from one
group cannot be extrapolated to the other group.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Medical diagnosis of sickle cell disease
• Age from 16 years old
• Written informed consent.
Exclusion criteria
- Refused informed consent
- For heart rate based measurements: medical history of arrhythmias and chronic
use of medication affecting the heart rate
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 | NL74534.018.20 |