Impact of Intra-Shift Napping on EMS Cardiovascular Health

Blood Pressure Clinical Trial

Official title:

The Impact of Napping During Night Shifts on Indicators of Cardiovascular Health Among EMS Clinicians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469803
• Other study ID #: STUDY19120222
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 2, 2022

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular disease (CVD) exerts a significant health burden among shift workers, including police, firefighters, and emergency medical services (EMS). The unique occupational demands inherent to these professions--sleep loss, circadian misalignment, high stress, and sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular events. Mitigating cardiovascular risks in these professions requires that we first identify robust markers and potential mechanisms of risk. Previous work suggest shift work has a negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both are linked to preclinical indicators of cardiac damage, such as presence of coronary artery calcium, left atrial enlargement, and cardiovascular-related mortality. This study will use an experimental crossover study design with three intervention conditions to test the impact of a 30 minute brief nap and a 2-hour longer nap versus no nap on BP and HRV. Outcomes of interest include blunted dipping of BP during nighttime hours and during sleep and HRV.

Description:

Cardiovascular disease (CVD) exerts a significant health burden among shift workers, including police, firefighters, and emergency medical services (EMS). The unique occupational demands inherent to these professions--sleep loss, circadian misalignment, high stress, and sustained hyper-vigilance--confer increased risk for both on and off-duty cardiovascular events. Mitigating cardiovascular risks in these professions requires that we first identify robust markers and potential mechanisms of risk. Previous work suggest shift work has a negative impact on blood pressure (BP) and heart rate variability (HRV). Blunted BP dipping at night and during sleep, and reduced HRV are powerful markers of increased CVD risk. Both are linked to preclinical indicators of cardiac damage, such as presence of coronary artery calcium, left atrial enlargement, and cardiovascular-related mortality.

Critical questions remain:

Are BP dipping and HRV impacted by napping during night shift work? Compared to those who do not nap, does napping during night shifts help BP and HRV to normalize quicker in the hours immediately post night shift work? What is the impact of brief naps (e.g., 30 minutes) versus longer naps (e.g., 2 hours)?

This study will use a randomized crossover experimental design of EMS workers and be based in the laboratory environment. Participants will complete three intervention conditions. All study arms will involve a 12-hour simulated night shift. The intervention of interest is napping (no nap vs. a 30 minute nap vs. a two-hour nap) in a randomized crossover study design. The primary outcome of interest is BP dipping (>10% drop) and Heart Rate Variability (HRV) measured as the standard deviation of inter-beat intervals of the sinus beats in milliseconds (SDNN). All outcomes will be measured serially before the simulation, during simulated night shifts, during the intra-shift napping period, and during recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2, 2022
• Est. primary completion date: October 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. age 18 years or older;

2. current / active certification as an EMS clinician at the EMT-Basic, Advanced, Paramedic, Flight Paramedic, or Flight Nurse level, or healthcare shift worker;

3. has not ever been diagnosed with any of the following: hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, adrenal disease, thyroid disease, rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss, organ transplantation; insomnia or other major sleep problem; sleep apnea or other diagnosis that is related to problems with breathing or the airway; and

4. is not currently pregnant.

Exclusion Criteria:

1. 17 years of age or younger;

2. not an EMS clinician or inactive as an EMS clinician or not a healthcare shift worker;

3. has ever been diagnosed with hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, adrenal disease, thyroid disease, rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss, organ transplantation; insomnia or other major sleep problem; sleep apnea or other diagnosis that is related to problems with breathing or the airway;

4. is currently pregnant;

5. is unwilling to wear multiple monitoring devices (e.g., automated blood pressure monitoring device, holter monitor for HRV measurement, wrist actigraphy) for the duration of the study protocol.

6. is unwilling to refrain from caffeine during the study protocol; or

7. is unwilling to adhere to sleep / wake times outlined in the study protocol.

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate Variability

Intervention

Behavioral:
• Intra-Shift Napping
The Brief Nap opportunity will allow for a 30-minute nap between the hours of 0200 and 0400 during the 12-hour simulated night shift. The Longer Nap opportunity will allow for a 2-hour nap between the hours of 0200 and 0400 during the 12-hour simulated night shift.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	ZOLL Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Patterson PD, Weiss LS, Weaver MD, Salcido DD, Opitz SE, Okerman TS, Smida TT, Martin SE, Guyette FX, Martin-Gill C, Callaway CW. Napping on the night shift and its impact on blood pressure and heart rate variability among emergency medical services workers: study protocol for a randomized crossover trial. Trials. 2021 Mar 16;22(1):212. doi: 10.1186/s13063-021-05161-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with blunted dipping of blood pressure via the sleep based method	Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip <10% is defined as blunted BP dipping. Blunted BP dipping will be quantified as: [(mean BP during waking hours - mean BP during sleep) / mean BP during waking hours] X 100 - the "sleep-based method."	Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
Primary	Number of participants with blunted dipping of blood pressure via the wide fixed time method	Blood pressure is created by the heart muscle contractions and is measured using two numbers: The Systolic Blood Pressure (SBP) and the Diastolic Blood Pressure (DBP). Normal patterns in BP include elevations in SBP and DBP during the daylight and waking hours followed by a drop (dip) during nighttime hours and during sleep. A dip of 10% to 20% during nighttime or sleep is considered normal, whereas a dip <10% is defined as blunted BP dipping. Blunted BP dipping during nighttime hours (2300 to 0659 hours) vs. daytime hours (0700 to 2259 hours) will be quantified as: [(mean daytime BP - mean nighttime BP) / mean daytime hours BP] X 100 - the "wide-fixed time method."	Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
Primary	The number of participants with unhealthy Heart Rate Variability (HRV) measured via the standard deviation of the inter-beat intervals of normal sinus beats (SDNN)	A healthy heart oscillates and beat-to-beat fluctuations are variable. Greater variability in heart rate is associated with better health, the capacity to respond and cope, and better performance. The Heart Rate Variability (HRV) measure standard deviation of the inter-beat intervals of normal sinus beats (SDNN) is considered standard and is calculated in milliseconds (ms) over short-term (e.g., 60 seconds) and long-term intervals (24 hours). Values of SDNN <50ms are considered unhealthy for medical risk stratification.	HRV will be monitored with a holter monitor continuously over 72 total hours