HospitalizationNCT06865781
Vital Signs Reduction Study
A study testing Forgone overnight vital signs in people with Hospitalization, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hospitalization
- What is being tested?
- Forgone overnight vital signs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
- Age 1-18 years
- Pediatric Early Warning Score ≤ 1 at 2000
- A parent/home caregiver present to consent to study
- Patient and home caregiver speak English or Spanish.
- Deemed appropriate for forgone overnight vital signs by care team (attending MD/Advanced Practice Provider and bedside RN).
Who cannot join
- Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
- Patients requiring O2 monitoring at home.
- The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
- Anaphylaxis within 24 hours
- Within the first 24 hours post-operative period
- Requiring oxygen above baseline
- Fever in the last 24 hours.
- Sepsis alert in the last 72 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Primary Children's Hospital
Salt Lake City, Utah, 84112
About this study
Official title: Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.
Read the detailed description
Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).
- Conditions
- Hospitalization
- Being tested
- Forgone overnight vital signs
- Keywords
- pediatric, hospitalization, vital signs, sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forgone overnight vital signsOther
No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Receive standard of care vital signs |
| Intervention group | Experimental | Will not receive vital signs at 0000 or 0400 of study night. Receives: Other: Forgone overnight vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Measured by actigraphy
Measured: From enrollment to end of treatment at 24 hours
Secondary outcomes (6)
Nocturnal wake frequency
By actigraphy
Measured: From enrollment to the end of treatment at 24 hours
Nocturnal wake duration
By actigraphy
Measured: From enrollment to the end of treatment at 24 hours
Total sleep time
By self report via sleep diary
Measured: From enrollment to the end of treatment at 24 hours
Overnight disruptions
By self report via sleep diary
Measured: From enrollment to the end of treatment at 24 hours
Restfulness upon waking
By self report via sleep diary
Measured: From enrollment to the end of treatment at 24 hours
Sleep disturbances
By self report via Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey
Measured: From enrollment to the end of treatment at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start17 Jul 2024
- Primary completion30 May 2025
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leandra Bitterfeld, MSN, Principal investigator, Intermountain Primary Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865781
- Sponsor's protocol ID
- 1052853
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared because participant consent does not include data sharing outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
- ClinicalTrials.gov ID
- NCT06865781
- Acronym / sponsor ID
- 1052853
- Conditions
- Hospitalization
- Keywords
- pediatric, hospitalization, vital signs, sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Mar 2025 (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.
Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.
Detailed description
Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Receive standard of care vital signs |
| Intervention group | Experimental | Other: Forgone overnight vital signsWill not receive vital signs at 0000 or 0400 of study night. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
- Age 1-18 years
- Pediatric Early Warning Score ≤ 1 at 2000
- A parent/home caregiver present to consent to study
- Patient and home caregiver speak English or Spanish.
Key exclusion criteria (8 listed)
- Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
- Patients requiring O2 monitoring at home.
- The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
- Anaphylaxis within 24 hours
- Within the first 24 hours post-operative period
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 |
|---|---|---|
| Forgone overnight vital signsNo vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400 | Other | Intervention group |
Primary outcome
Total sleep time
Time frame: From enrollment to end of treatment at 24 hours
Measured by actigraphy
6 secondary outcomes
Nocturnal wake frequency
Time frame: From enrollment to the end of treatment at 24 hours
Nocturnal wake duration
Time frame: From enrollment to the end of treatment at 24 hours
Total sleep time
Time frame: From enrollment to the end of treatment at 24 hours
Overnight disruptions
Time frame: From enrollment to the end of treatment at 24 hours
Restfulness upon waking
Time frame: From enrollment to the end of treatment at 24 hours
Sleep disturbances
Time frame: From enrollment to the end of treatment at 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No. Individual patient data will not be shared because participant consent does not include data sharing outside of the study team.
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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.
Leandra Bitterfeld, MSN principal investigator
Intermountain Primary Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forgone overnight vital signs in people with Hospitalization, run by Intermountain Health Care, Inc. 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total sleep time (time frame: From enrollment to end of treatment at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.