Smart Watch, Heart Rate and So2 in Chronic Patients

NCT05271864 | Completed DMC

• 1 other identifier: HAPO-02-K-012-2022-02-959
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Disease

Keywords

Oxygen saturation; Heart rate; diabetes mellites; Hypertension; hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Oxygen Saturation

  over 10 minutes at rest

• Oxygen Saturation

  over 10 minutes after exercise

Secondary Outcomes (1)

• Heart rate

  over 31 minutes

Study Arms (3)

Group A

diabetes mellites

Device: Apple Watch

Group B

hypertension

Device: Apple Watch

Group C

hyperlipidemia

Device: Apple Watch

Interventions

Apple Watch DEVICE

Apple Watch

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetic mellites, hypertension and hyperlipidemia

You may qualify if:

• 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
• Hyperlipidemia

You may not qualify if:

• patients with :
• Uncontrolled diabetes mellitus.
• Uncontrolled hypertension.
• Uncontrolled hyperlipidemia will be all excluded from the study.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura medical center

Al Makhwāh, Mecca Region, 21234, Saudi Arabia

Location

Related Publications (1)

• Khushhal AA, Mohamed AA, Elsayed ME. Accuracy of Apple Watch to Measure Cardiovascular Indices in Patients with Chronic Diseases: A Cross Sectional Study. J Multidiscip Healthc. 2024 Mar 11;17:1053-1063. doi: 10.2147/JMDH.S449071. eCollection 2024.

  PMID: 38496326 DERIVED

MeSH Terms

Conditions

Chronic Disease; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 9, 2022
• Study Start: November 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

SA (1)