Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05271864 |
| Other study ID # |
HAPO-02-K-012-2022-02-959 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
July 30, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Umm Al-Qura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Apple watch validity to measure the heart rate (HR) and oxygen saturation (Spo2)
in healthy subjects has been investigated, but its accuracy and validity for patients with
chronic non-communicable diseases such as diabetes mellites (DM), hyperlipidemia and
hypertension (HTN) is still unclear. Patients with chronic diseases as DM, HTN and
hyperlipidemia who have hypoxemia are advised to continuously monitor their Spo2. Therefore,
this study aims to investigate the accuracy of the Apple watch in measuring the Spo2 and
heart rate in patients with chronic diseases.
Method: A cross sectional study will invite ninety-five patients with chronic diseases to
participate in this study and the eligible participants will be allocated into three groups.
The first group (Group-A) will include patients with the DM, the second group (Group-B) will
include the patients with HTN and the third group will include patients with hyperlipidemia.
All participants will use the apple watch to evaluate the Spo2 against the pulse oximeter at
rest. The main outcome will be the Spo2 and heart rate that will be evaluated at rest and
before and after exercise for 15 minutes using the Apple watch, Spo2 and Polar HR monitored
using the pulse oximeter.
Description:
Introduction:
Assessment of the heart rate (HR) is an essential process to determine proper exercise
training intensity. (1) Utilization of the 12-leads electrocardiogram (ECG) is considered
most objective heart rate assessment procedure. Polar chest strap arises as an alternative to
the ECG when it is not accessible to use it outside the laboratories. The Polar chest strap
proved valid and reliable instrument when tested against the ECG in healthy subjects (2-4)
and patients with cardiac diseases (5) at rest and during training. Monitoring the resting as
well as the post-training heart rate (heart rate recovery) is essential because it helps
predicting the cardiopulmonary fitness level as well as the mortality risk among evaluated
personnel. (6)
Diabetes mellitus is a rapidly growing non-communicable chronic disease worldwide, becoming
one of the most alarming health problems in the 21st century. The overall estimated
prevalence of diagnosed diabetes in 2018 was 26.9 million US subject of all ages (8.2% of the
US population) (7) The International Diabetes Federation (IDF) has estimated the total number
of persons with DM across the world will rise from 536.6 million in 2021 to 783.2 million by
2045, with about 94% of the increase in the number of subjects with diabetes by 2045 will be
within the low and middle-income countries. The global incidence also projected to increase
from 16.3% in 2021 to 19.2% by 2025 in middle- and low-income countries. The prevalence of
diabetes in adults (20-79 years old) in the Middle East and North Africa was estimated to be
16.2% compared to 19.3% in 2045. (8) Hypertension possess significantly increased public
health risk and population challenge. The prevalence of hypertension was 6.0, 4.2 and 4.9% in
male, female and all subjects, respectively. (9) Hypertension prevalence is increasing in
KSA, the rate exceeds 25% among the adult Saudi subjects. Monitoring the hypertension-related
disturbances is an urgent concept to prevent its organs-damaging. (10) Regional study at
Majmaah, Saudi Arabia reported that the hypercholesterolemia prevalence was 45.3%, with no
significant difference between both genders. (11) A study by Al-Nozha et al., reported that
the hyperlipidemia continues reaching higher prevalence rate recently. The
hypercholesterolemia prevalence among the 30-70 years old subjects reached 54.9% and 53.2%
for males and females respectively, Hypertriglycemia prevalence was 47.6% in male compared to
33.7% in females. (12) More recently; a study by reported that the prevalence of
Hypercholesterolemia among Saudi population ≥ years old is around 12.5%, with males have
higher rate (56.7%) compared to females who have lower s rate (43.3%). Close monitoring of
the vital signs and cardiovascular variables in patients with chronic non-communicable
diseases is indicated since many harmful consequences can be prevented via increasing
community awareness and education. (13) Diabetes Mellitus is chronic debilitating disorder
requires well-organized efforts and continuous monitoring to limit the impact of
disease-associated hazards and long-term complications. (14) The process of SpO2 evaluation
is important because it indirectly reflects the subject's organs oxygen requirements. The
traditional SpO2 measuring procedure is invasive and painful, requiring collection and assay
of arterial blood sample using a blood gas analyzer. (15) Previous trials proposed evaluating
the SpO2 non-invasively using simple procedure, with keeping maximum accuracy. (16) Pulse
oximetry is a well-known noninvasive instrument used for monitoring and evaluation of SpO2).
(17) Routine and frequent screening of patients with chronic diseases is recommended
especially with age over 50 years and presence of other comorbidities as HTN and
hyperlipidemia. (18) Pulse oximetry is used to measure the level of the SpO2, with low blood
flow is associated with lower SpO2. (19) The HR is tightly and linearly correlated with the
oxygen consumption at specified time point.(20) Monitoring of other vital variables as the
oxygen saturation (SpO2) is recommended in patients suffering hypoxia to improve their
survival, (21) as in post-operative and post-arrest cardiac patients, (22) with the pulse
oximeter is the widely used instrument to evaluate the SpO2 because of accuracy and ease of
application. (23) Quiet recently; the Apple smart watch appeared as a new tool to measure the
HR. all the Apple watch versions can monitor the HR, but the blood SpO2 can be only measured
by only the latest 6 and 7 versions. The concept of utilizing the Apple watch to measure the
HR depends on the Photoplethysmography (PPT) non-invasive measurement procedure applied using
wrist-worn watch that continuously monitors both heart beats and blood color changes over
time. The PPT is a commonly used approach to measure the cardiac output, blood pressure and
SpO2 in verities of medical instruments, (24) that can help discovering the cardiovascular
insults and complications at early stages. (25) Implemented new technology and updated
features that enable the Apple watch to monitor the HR is available only in updated series-6
and 7. Very limited number of studies evaluated the validity of the Apple watch against pulse
oximeter in measuring the SpO2 (the Spo2 was evaluated in 23 patients with chronic
obstructive pulmonary disease, 61 patients with interstitial lung diseases and 16 health
control subjects). the Apple watch results showed strong positive correlations with that of
the pulse oximeter (r=0.81, P<0.0001), furthermore; this study recommended testing the Apple
watch validity for measuring the SpO2 in other groups of patients. (26) The Apple watch is a
smart instrument with advanced technology measuring the Spo2 and heart rate but its validity
in patients with chronic diseases including patients with diabetic mellites, hypertension and
hyperlipidemia is still unknown. Therefore, this will be the first study to evaluate the
Apple watch accuracy and validity in measuring the Spo2 and heart rate in patients with
chronic diseases including diabetic mellitus, hypertension, hyperlipidemia.
Method:
A cross sectional study will be conducted, ninety-five chronic patients will be invited to
participate in this study. The study design will be in form of 3-groups: first group will
include 35 patients with diabetes and the second group will include 35 patients with
hypertension. The third group will be around 35 patients with hyperlipidemia. The
distribution of patients and number of groups will be based on the availability of the
patients with chronic non-communicable diseases at Umm Al-Qura University Medical Center. All
participants in this study will wear the Polar chest strap HR and the Apple Watch at rest,
during short session of mild to moderate intensity exercise [50-70% (maximum heart
rate-Resting heart rate) + resting heart rate] for 15 minutes and after exercise. The pulse
oximeter will be used at rest (pre) and after exercise.
Under resting condition; the pulse oximeter will be fitted on a warm finger while the
participant assumes setting position, with the patient in the upright (sitting) position and
resting. The SpO2 reading will be recorded after being stabilized on the pulse oximeter
instrument. (27, 28) The exercise session will be about 15-minutes duration at mild to
moderate intensity according to the heart rate reserve (HRR) using the treadmill and the
cycle ergometer, preceded by a 3-minutes warm-up, and followed by 3-minutes cool-down. The HR
will be recorded every 30 seconds during whole period and the oxygen saturation will be
recorded five times at rest and after exercises.
This study will follow the Declaration of Helsinki 1975 principles, revised in 2000 and will
be conducted at the Umm Al-Qura University Medical Center, and will be in line with the
Faculty of Applied Medical Sciences, Umm Al-Qura University ethical guidelines. Each
participant will sign a written consent approving the volunteer participation in this study
and agreeing for publication of its results. Suitable sample size was be computed using the
online G-power tool (https://download.cnet.com/G-Power/3000-2054_4-10647044.html),
considering the effect size = 0.5, giving a sample size of 54 participants to provide
reliable results. Extra-number will be included to substitute any participant's withdrawal or
discontinuation.
Inclusion criteria: eligible participants will be patients with chronic diseases as those
with stable diabetes mellitus type 1 or 2, hypertension but not more than 180 mm.Hg and
patients with hyperlipidemia.
Exclusion criteria: patients with uncontrolled diabetes mellitus, uncontrolled hypertension
and hyperlipidemia will be all excluded from the study. Also, patient with other disease
rather than that described in the inclusion criteria will be also excluded.
Risk management:
All measurements in this study will be done as the normal measurements for each patient with
chronic non-communicable disease who visited the Umm Al-Qura University Medical Center, so
there is no risk for the patients to take part in this study. In case any terribly ill happen
because of the study procedure, the cardiologist (Dr. Mahmoud) will supervise each patient in
this study.
Data analysis:
All data will enter into the SPSS program for analyses. First, a descriptive analysis will be
performed to show results in form of means and standard deviations. The results of this study
will be analyzed using the Pearson correlation test to test the difference between the apple
watch and the Pulse oximeter in measuring SpO2 and heart rate in measuring heart rate to test
Apple watch validity. The P value will be set at 0.05 for significant results.
