The Feasibility to Use Wearable Devices to Collect Physiologic Data During Night Shifts - A Pilot Study

NCT03640416 | Unknown

• 1 other identifier: 0375-17-RMB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There is an increase interest in the use of wearable activity trackers and wearable technology in the various medical fields. Such devices can increase physical activity and decrease weight significantly. Field and laboratory studies have shown that shift work can alter circadian rhythms, disrupt the sleep cycle, and hinder human performance. Sleep deprivation reduces alertness level, and may increase reaction time, cause memory impairment and impaired motor skills. Disrupted circadian rhythms, a well-known consequence of atypical work schedules, have been linked to neurodegeneration. The aim of this pilot study is to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions. The study population will include 30 Rambam Health Care Campus medical residents who work nights on call. The length of experiment per participant will be one month. Subjective data on stress will be collected during the study. Data on vital signs and sleep stages will be collected through a smart watch Fitbit® Charge HR.

Conditions

Sleep Deprivation; Stress

Keywords

night on call; sleep deprivation; fitbit®; smart watch; stress

Outcome Measures

Primary Outcomes (1)

• assessment of sleep duration (hours)

  calculated using the Fitbit® charge HR device

  one month per participant

Secondary Outcomes (4)

• heart rate (beats/mins)

  one month per participant

• blood pressure (mmhg)

  one month per participant

• steps taken (number)

  one month per participant

• Trail Making test

  one month per participant

Study Arms (1)

Medical residents

OTHER

Rambam Health Care Campus medical residents who work nights on call. Fitbit® Charge HR smart watch

Device: Fitbit® Charge HR smart watch

Interventions

Fitbit® Charge HR smart watch DEVICE

The Fitbit® Charge HR is a commercial product widely used worldwide, and data from the device is sent to a secured online server and can be accessed by each user to see only data collected from his own device. Data collected from the Fitbit® Charge HR is described earlier.

Medical residents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A medical resident working nights on call at Rambam.
• Use a smart phone (Android OS) with a data plan.

You may not qualify if:

• Pregnancy and lactation.
• Medications:
• CNS (Central Nervous System) stimulants - Ritalin (methyphenidate), Concerta.
• Beta Blockers, Calcium channel Blockers
• glucocorticoids
• Sedatives
• Unwilling to carry smart phone or wearable device on a continuous basis during shifts and at least 24 hours before and after shifts.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 32000, Israel

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Lea Bentur, MD

CONTACT

04-7774360; l_bentur@rambam.health.gov.il

Kamal Masarweh, MD

CONTACT

04-7774360; m_kamal@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking needed.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)