Blood PressureNCT05436951
Night Shift Work, On-shift Napping, and Endothelial Function: A Pilot Study
A study testing Brief on-shift nap in people with Blood Pressure and Endothelial Dysfunction, run by University of Pittsburgh at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. 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, Endothelial Dysfunction
- What is being tested?
- Brief on-shift nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 4 Mar 2023
- 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
- All participants will be working aged adults (18 years of age or older). Investigators are interested in enrolling public safety workers and healthcare workers given how often this group works night shifts.
- Criteria that participants will need to address:
- 18 years of age or older;
- Currently licensed or certified as an EMS clinician, other public safety shift worker, or other type of healthcare clinicians and actively working in Western Pennsylvania as an EMT, Paramedic, Flight Nurse/Paramedic, other EMS clinician, firefighter, or other type of healthcare clinician (e.g., nurse, physician, physician assistants, patient care technician, or other healthcare clinician);
- a 'no' answer to #2 above is not a criterion for exclusion.
Who cannot join
- Having ever been diagnosed with the following: hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, liver disease, adrenal disease, thyroid disease, rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss, organ transplantation; major sleep problem; heavy alcohol use; sleep apnea or other diagnosis that is related to problems with breathing or the airway;
- Current pregnancy;
- Insomnia is NOT a criterion for exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Cardiovascular disease (CVD) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. The purpose of this pilot study is to assess feasibility of collecting data germane to key indicators of cardiovascular health (i.e., ambulatory blood pressure) repeatedly during a simulated night shift protocol. The primary outcome measure will be the number of participants for which at least 70% of required ambulatory BP measures were collected. A result of at least 10 participants/subjects will be considered feasible.
Read the detailed description
Cardiovascular disease (CVD) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. Risk of CVD events such as myocardial infarction and stroke are higher among shift workers than non-shift workers. Risk of atrial fibrillation is 1.22 times greater (95%CI 1.02, 1.45) among individuals that work 3-to-8 night shifts per month versus non-shift workers. A comprehensive explanation for why shift workers, especially night shift workers, are at greater risk of CVD is not yet available. However, some research suggests that night shift workers experience repeated exposure to sleep deprivation, which impacts normal patterns in BP and endothelial function. Endothelial dysfunction and disruption of normal BP patterns are independently linked to numerous indicators of CVD, including cardiac-related mortality.
The purpose of this pilot study is to assess feasibility of collecting data germane to key indicators of cardiovascular health (i.e., ambulatory blood pressure) repeatedly during a simulated night shift protocol. Investigators propose a laboratory-based pilot study whereby participants (volunteers) complete two conditions. Condition one will include a 12-hour simulated night shift in our lab with no napping. Condition two will involve a 12-hour simulated night shift in our lab with a 45 minute nap at 0200 hours. Participants will be asked to wear monitoring devices for approximately 48 total hours with the last 12 hours of monitoring (from 1900 to 0700) to be in our lab.
Aim 1: Assess the feasibility of collecting ambulatory BP measures (ABPM) and indicators of endothelial function at multiple time points prior to, during, and after simulated night shift work.
The primary outcome measure will be the number of participants for which at least 70% of required ambulatory BP measures were collected. A result of at least 10 participants/subjects will be considered feasible.
Aim 2: Characterize the impact of simulated night shift work and on-shift napping on BP dipping and endothelial function.
Secondary endpoints include quantifying descriptive statistics (e.g., means and standard deviations) for BP dipping and endothelial function.
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Being tested
- Brief on-shift nap
- Keywords
- Ambulatory Blood Pressure, Endothelial Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief on-shift napBehavioural
The brief nap opportunity will allow for a 45-minute nap between the hours of 0200 and 0300 during the in-lab 12-hour simulated night shift.
| Study group | Role | What they receive |
|---|---|---|
| No-nap, then brief 45-minute nap | Experimental | Participants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with no nap first, undergo a minimum of 1-week washout, then return complete the 48-hour protocol again with the brief 45-minute nap. Receives: Behavioral: Brief on-shift nap |
| The brief 45-minute nap, then no-nap | Experimental | Participants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with the brief 45-minute nap, undergo a 1-week minimum washout, then return to complete the 48-hour protocol again with the no-nap Receives: Behavioral: Brief on-shift nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for which at least 70% of required Ambulatory BP readings were collected
A result of at least 10 participants will be considered feasible
Measured: 48 continuous hours for each arm/condition
Secondary outcomes (4)
Average blood pressure while awake during simulated night shift
The mean and standard deviation of blood pressure measurements taken while participant is awake during the 12-hour simulated night shift
Measured: 12 continuous hours for each arm/condition
Average blood pressure while napping during simulated night shift
The mean and standard deviation of blood pressure measurements taken while participant is napping (sleeping) during the 12-hour simulated night shift that includes the 45-minute nap condition.
Measured: 45 minutes
Average Reactive Hyperemia Index (RHI) at baseline
The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed at baseline
Measured: 20-30 minutes for each arm/condition
Average Reactive Hyperemia Index (RHI) after simulated night shift
The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed after the 12-hour simulated night shift
Measured: 20-30 minutes for each arm/condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start28 Jun 2022
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Patterson, PhD, NRP, University of Pittsburgh
- Investigators
- P. Daniel Patterson, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436951
- Sponsor's protocol ID
- STUDY22040156
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not have an existing plan to share data after the study has been completed. However, the investigators will develop a process to receive requests for de-identified data from outside investigators once the study has been completed.
Publications
Patterson PD, Hilditch CJ, Martin SE, Roach DGL, Weaver MD, Okerman TS, Hostler D, Weiss LS, Reis SE. Comparison of 45-min nap versus no-nap during simulated night shift work on endothelial function: a randomized crossover feasibility trial. Pilot Feasibility Stud. 2024 Nov 12;10(1):137. doi: 10.1186/s40814-024-01569-2.
PubMed 39533414
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night Shift Work, On-shift Napping, and Endothelial Function: A Pilot Study
- ClinicalTrials.gov ID
- NCT05436951
- Acronym / sponsor ID
- STUDY22040156
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Keywords
- Ambulatory Blood Pressure, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 29 Jun 2022 (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) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. The purpose of this pilot study is to assess feasibility of collecting data germane to key indicators of cardiovascular health (i.e., ambulatory blood pressure) repeatedly during a simulated night shift protocol. The primary outcome measure will be the number of participants for which at least 70% of required ambulatory BP measures were collected. A result of at least 10 participants/subjects will be considered feasible.
Detailed description
Cardiovascular disease (CVD) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. Risk of CVD events such as myocardial infarction and stroke are higher among shift workers than non-shift workers. Risk of atrial fibrillation is 1.22 times greater (95%CI 1.02, 1.45) among individuals that work 3-to-8 night shifts per month versus non-shift workers. A comprehensive explanation for why shift workers, especially night shift workers, are at greater risk of CVD is not yet available. However, some research suggests that night shift workers experience repeated exposure to sleep deprivation, which impacts normal patterns in BP and endothelial function. Endothelial dysfunction and disruption of normal BP patterns are independently linked to numerous indicators of CVD, including cardiac-related mortality.
The purpose of this pilot study is to assess feasibility of collecting data germane to key indicators of cardiovascular health (i.e., ambulatory blood pressure) repeatedly during a simulated night shift protocol. Investigators propose a laboratory-based pilot study whereby participants (volunteers) complete two conditions. Condition one will include a 12-hour simulated night shift in our lab with no napping. Condition two will involve a 12-hour simulated night shift in our lab with a 45 minute nap at 0200 hours. Participants will be asked to wear monitoring devices for approximately 48 total hours with the last 12 hours of monitoring (from 1900 to 0700) to be in our lab.
Aim 1: Assess the feasibility of collecting ambulatory BP measures (ABPM) and indicators of endothelial function at multiple time points prior to, during, and after simulated night shift work.
The primary outcome measure will be the number of participants for which at least 70% of required ambulatory BP measures were collected. A result of at least 10 participants/subjects will be considered feasible.
Aim 2: Characterize the impact of simulated night shift work and on-shift napping on BP dipping and endothelial function.
Secondary endpoints include quantifying descriptive statistics (e.g., means and standard deviations) for BP dipping and endothelial function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover study design
| Arm | Type | Receives |
|---|---|---|
| No-nap, then brief 45-minute nap | Experimental | Behavioral: Brief on-shift napParticipants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with no nap first, undergo a minimum of 1-week washout, then return complete the 48-hour protocol again with the brief 45-minute nap. |
| The brief 45-minute nap, then no-nap | Experimental | Behavioral: Brief on-shift napParticipants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with the brief 45-minute nap, undergo a 1-week minimum washout, then return to complete the 48-hour protocol again with the no-nap |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All participants will be working aged adults (18 years of age or older). Investigators are interested in enrolling public safety workers and healthcare workers given how often this group works night shifts.
- 18 years of age or older;
- Currently licensed or certified as an EMS clinician, other public safety shift worker, or other type of healthcare clinicians and actively working in Western Pennsylvania as an EMT, Paramedic, Flight Nurse/Paramedic, other EMS clinician, firefighter, or other type of healthcare clinician (e.g., nurse, physician, physician assistants, patient care technician, or other healthcare clinician);
- a 'no' answer to #2 above is not a criterion for exclusion.
Key exclusion criteria (3 listed)
- Having ever been diagnosed with the following: hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, liver disease, adrenal disease, thyroid disease, rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss, organ transplantation; major sleep problem; heavy alcohol use; sleep apnea or other diagnosis that is related to problems with breathing or the airway;
- Current pregnancy;
- Insomnia is NOT a criterion for exclusion.
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 |
|---|---|---|
| Brief on-shift napThe brief nap opportunity will allow for a 45-minute nap between the hours of 0200 and 0300 during the in-lab 12-hour simulated night shift. | Behavioural | No-nap, then brief 45-minute nap, The brief 45-minute nap, then no-nap |
Primary outcome
Number of Participants for which at least 70% of required Ambulatory BP readings were collected
Time frame: 48 continuous hours for each arm/condition
A result of at least 10 participants will be considered feasible
4 secondary outcomes
Average blood pressure while awake during simulated night shift
Time frame: 12 continuous hours for each arm/condition
Average blood pressure while napping during simulated night shift
Time frame: 45 minutes
Average Reactive Hyperemia Index (RHI) at baseline
Time frame: 20-30 minutes for each arm/condition
Average Reactive Hyperemia Index (RHI) after simulated night shift
Time frame: 20-30 minutes for each arm/condition
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 8 Jan 2024.
- Derived from this study: PubMed 39533414Patterson PD, Hilditch CJ, Martin SE, Roach DGL, Weaver MD, Okerman TS, Hostler D, Weiss LS, Reis SE. Comparison of 45-min nap versus no-nap during simulated night shift work on endothelial function: a randomized crossover feasibility trial. Pilot Feasibility Stud. 2024 Nov 12;10(1):137. doi: 10.1186/s40814-024-01569-2.
- Individual participant dataSharing planned: No. The investigators do not have an existing plan to share data after the study has been completed. However, the investigators will develop a process to receive requests for de-identified data from outside investigators once the study has been completed.
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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.
P. Daniel Patterson principal investigator
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 Brief on-shift nap in people with Blood Pressure and Endothelial Dysfunction, 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 5 inclusion and 3 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 8 Jan 2024. 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 for which at least 70% of required Ambulatory BP readings were collected (time frame: 48 continuous hours for each arm/condition). 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 NCT05436951, which also lists 1 linked publication.
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 8 Jan 2024.