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NCT04469803 · ClinicalTrials.gov registry record · NA
Impact of Intra-Shift Napping on EMS Cardiovascular Health
A NA study of Blood Pressure and Heart Rate Variability, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04469803: Completed NA study of Blood Pressure and Heart Rate Variability, sponsored by University of Pittsburgh.
NCT04469803 is a NA study of Blood Pressure and Heart Rate Variability that has completed, run by University of Pittsburgh. The registered enrollment target is 28 participants, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04469803, a NA study of Blood Pressure and Heart Rate Variability, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 B
Conditions Studied
Interventions
- BEHAVIORAL Intra-Shift Napping
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2022-10-02 |
| Phase | NA |
What the finished NCT04469803 record still lists
NCT04469803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 287-participant average among 101 other Blood Pressure trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Blood Pressure appearing as the primary indexed condition, and to 1 intervention - of which Intra-Shift Napping is the first listed.
NCT04469803 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04469803 about?
NCT04469803 is a clinical study titled "Impact of Intra-Shift Napping on EMS Cardiovascular Health". 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--co...
What is the current status of trial NCT04469803?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2021-03-01. Estimated completion is 2022-10-02.
What conditions does trial NCT04469803 study?
This clinical trial studies the following conditions: Blood Pressure, Heart Rate Variability.
What interventions are being tested in trial NCT04469803?
The interventions under investigation include: Intra-Shift Napping (BEHAVIORAL).
Who is sponsoring clinical trial NCT04469803?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04469803 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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