Blood PressureNCT04469803
Impact of Intra-Shift Napping on EMS Cardiovascular Health
A study testing Intra-Shift Napping in people with Blood Pressure and Heart Rate Variability, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate Variability
- What is being tested?
- Intra-Shift Napping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 2 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older;
- current / active certification as an EMS clinician at the EMT-Basic, Advanced, Paramedic, Flight Paramedic, or Flight Nurse level, or healthcare shift worker;
- 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
- is not currently pregnant.
Who cannot join
- 17 years of age or younger;
- not an EMS clinician or inactive as an EMS clinician or not a healthcare shift worker;
- 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;
- is currently pregnant;
- 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.
- is unwilling to refrain from caffeine during the study protocol; or
- is unwilling to adhere to sleep / wake times outlined in the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: The Impact of Napping During Night Shifts on Indicators of Cardiovascular Health Among EMS Clinicians
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.
Read the detailed 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.
- Conditions
- Blood Pressure, Heart Rate Variability
- Being tested
- Intra-Shift Napping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Shift NappingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No nap, brief nap, then longer nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity. Receives: Behavioral: Intra-Shift Napping |
| No nap, longer nap, then brief nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity. Receives: Behavioral: Intra-Shift Napping |
| Brief nap, no nap, then longer nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity. Receives: Behavioral: Intra-Shift Napping |
| Brief nap, longer nap, then no nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity. Receives: Behavioral: Intra-Shift Napping |
| Longer nap, brief nap, then no nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity. Receives: Behavioral: Intra-Shift Napping |
| Longer nap, no nap, then brief nap | Experimental | Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity. Receives: Behavioral: Intra-Shift Napping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
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."
Measured: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
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.
Measured: HRV will be monitored with a holter monitor continuously over 72 total hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Mar 2021
- Primary completion2 Oct 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover study design
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- ZOLL Foundation
- Responsible party
- Principal investigator, Leonard Weiss, University of Pittsburgh
- Investigators
- Leonard Weiss, MD, Principal investigator, University of PittsburghP. Daniel Patterson, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469803
- Sponsor's protocol ID
- STUDY19120222
- Status last verified
- May 2023
- First submitted
- 9 Jul 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will work with the ZOLL Foundation and share de-identified research data if requested and if approved by the University of Pittsburgh. The study team will develop a process to receive requests from outside the study team for de-identified datasets.
Publications
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.
PubMed 33726840Patterson PD, Okerman TS, Roach DGL, Hilditch CJ, Weaver MD, Patterson CG, Sheffield MA, Di Salvatore JS, Bernstein H, Georges G, Andreozzi A, Willson CM, Jain D, Martin SE, Weiss LS. Are Short Duration Naps Better than Long Duration Naps for Mitigating Sleep Inertia? Brief Report of a Randomized Crossover Trial of Simulated Night Shift Work. Prehosp Emerg Care. 2023;27(6):807-814. doi: 10.1080/10903127.2023.2227696. Epub 2023 Jul 17.
PubMed 37347968Patterson PD, Okerman TS, Roach DGL, Weaver MD, Patterson CG, Martin SE, Okwiya N, Nong L, Eyiba C, Huff JR, Ruzicka A, Ruggieri J, McIlvaine Q, Weiss LS. Effect of Short versus Long Duration Naps on Blood Pressure during Simulated Night Shift Work: A Randomized Crossover Trial. Prehosp Emerg Care. 2023;27(6):815-824. doi: 10.1080/10903127.2023.2227891. Epub 2023 Jul 17.
PubMed 37347964
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Napping During Night Shifts on Indicators of Cardiovascular Health Among EMS Clinicians
- ClinicalTrials.gov ID
- NCT04469803
- Acronym / sponsor ID
- STUDY19120222
- Conditions
- Blood Pressure, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- ZOLL Foundation
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomized crossover study design
| Arm | Type | Receives |
|---|---|---|
| No nap, brief nap, then longer nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity. |
| No nap, longer nap, then brief nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity. |
| Brief nap, no nap, then longer nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity. |
| Brief nap, longer nap, then no nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity. |
| Longer nap, brief nap, then no nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity. |
| Longer nap, no nap, then brief nap | Experimental | Behavioral: Intra-Shift NappingParticipants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older;
- current / active certification as an EMS clinician at the EMT-Basic, Advanced, Paramedic, Flight Paramedic, or Flight Nurse level, or healthcare shift worker;
- 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
- is not currently pregnant.
Key exclusion criteria (7 listed)
- 17 years of age or younger;
- not an EMS clinician or inactive as an EMS clinician or not a healthcare shift worker;
- 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;
- is currently pregnant;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-Shift NappingThe 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. | Behavioural | Brief nap, longer nap, then no nap, Brief nap, no nap, then longer nap, Longer nap, brief nap, then no nap, Longer nap, no nap, then brief nap, No nap, brief nap, then longer nap, No nap, longer nap, then brief nap |
Primary outcome
Number of participants with blunted dipping of blood pressure via the sleep based method
Time frame: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
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."
Number of participants with blunted dipping of blood pressure via the wide fixed time method
Time frame: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours
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."
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)
Time frame: HRV will be monitored with a holter monitor continuously over 72 total hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 33726840Patterson 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.
- Derived from this study: PubMed 37347968Patterson PD, Okerman TS, Roach DGL, Hilditch CJ, Weaver MD, Patterson CG, Sheffield MA, Di Salvatore JS, Bernstein H, Georges G, Andreozzi A, Willson CM, Jain D, Martin SE, Weiss LS. Are Short Duration Naps Better than Long Duration Naps for Mitigating Sleep Inertia? Brief Report of a Randomized Crossover Trial of Simulated Night Shift Work. Prehosp Emerg Care. 2023;27(6):807-814. doi: 10.1080/10903127.2023.2227696. Epub 2023 Jul 17.
- Derived from this study: PubMed 37347964Patterson PD, Okerman TS, Roach DGL, Weaver MD, Patterson CG, Martin SE, Okwiya N, Nong L, Eyiba C, Huff JR, Ruzicka A, Ruggieri J, McIlvaine Q, Weiss LS. Effect of Short versus Long Duration Naps on Blood Pressure during Simulated Night Shift Work: A Randomized Crossover Trial. Prehosp Emerg Care. 2023;27(6):815-824. doi: 10.1080/10903127.2023.2227891. Epub 2023 Jul 17.
- Individual participant dataSharing planned: Yes. The investigators will work with the ZOLL Foundation and share de-identified research data if requested and if approved by the University of Pittsburgh. The study team will develop a process to receive requests from outside the study team for de-identified datasets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Weiss, MD principal investigator
University of Pittsburgh
P. Daniel Patterson, PhD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Shift Napping in people with Blood Pressure and Heart Rate Variability, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with blunted dipping of blood pressure via the sleep based method (time frame: Blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.