SleepNCT05065203
Evaluation of Inpatient Sleep and Activity Following Childbirth
An observational study of Sleep, run by Stanford University at 1 site in United States.
Trial summary
Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Sleep
- What is being tested?
- planned or unplanned Cesarean, operative, or non operative delivery
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 31 Jan 2023
- Phase
- Observational
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: All pregnant women booked to deliver their child(ren) at Lucile Packard Children's Hospital. Eligible and consenting patients enrolled will wear an Actigraph watch during their inpatient stay (from preoperative period if undergoing cesarean delivery or during labor if undergoing a planned vaginal delivery).
Who may be able to join
- over 18 years old
- live pregnancy
- Single or multiple gestation
- all gestational ages
Who cannot join
- Weekend delivery
- admitted to critical care
- unable to speak or understand English
- known sleeping disorder
- opioid requirement prior to admission
- long term steroids use
- significant autoimmune or neurological disease
- significant psychiatric or neurodevelopment disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Little is known about sleep and activity levels in inpatients during nighttime and daytime following childbirth and how this may affect their mental and physical health and wellbeing. If abnormalities are identified, targeted interventions may be possible to optimize recovery following delivery.
- Conditions
- Sleep
- Being tested
- planned or unplanned Cesarean, operative, or non operative delivery
- Keywords
- Postpartum sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
planned or unplanned Cesarean, operative, or non operative deliveryProcedure or surgery
All types of delivery
| Study group | Role | What they receive |
|---|---|---|
| Postpartum patients | Women booked and have delivery of their child(ren) at Lucile Packard Children's Hospital Receives: Procedure: planned or unplanned Cesarean, operative, or non operative delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of inpatient postpartum sleep using actigraphy
Participants will wear an acitgraphy watch during their inpatient stay to measure sleep.
Measured: During inpatient stay (up to 7 days)
Secondary outcomes (6)
Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)
Measurement of postpartum actigraphy data to associate with patient reported outcome measures (PROM) (ObsQoR-10, Edinburgh Postpartum Depression Score, WHO-QOL-BREF and Bergen Insomnia Scale Score) given by face to face then remote interview
Measured: Day 1-7, 6 and 12 weeks
Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep.
Measured: During inpatient stay and outpatient follow up (up to 7 days)
Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
Participants will be interviewed at 6 and 12 weeks with PROM questions and sleep diaries to assess for association with demographic, medical obstetric, psychiatric neonatal and anaesthetic factors.
Measured: 6 and 12 weeks
Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs
Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6- 12 week interview.
Measured: Day 1-7, 6 and 12 weeks
Determine population norms of objective and subjective sleep measures in the postpartum population.
Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6 and 12 week interview.
Measured: Day 1-7, 6 and 12 weeks
Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures
Participants will wear an acitgraphy watch during their inpatient stay to measure physical activity and sleep. PROM survey data during inpatient day 1-7 and outpatient 6 and 12 week interview.
Measured: Day 1-7, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start21 Oct 2021
- Primary completion30 Sep 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PSultan, Stanford University
- Investigators
- Pervez Sultan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065203
- Sponsor's protocol ID
- 60762
- Status last verified
- Jun 2023
- First submitted
- 22 Sep 2021
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected from the watches will not be available to share with other researchers. Anonymous and aggregated data will be available for verification only on request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inpatient Sleep and Activity Following Childbirth
- ClinicalTrials.gov ID
- NCT05065203
- Acronym / sponsor ID
- 60762
- Conditions
- Sleep
- Keywords
- Postpartum sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Oct 2021 (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.
Sleep is critical to mental and physical health following childbirth. However, patients who are hospitalized for labor and delivery may be admitted for days with significant impacts on sleep levels. Little is known about sleep and activity levels in inpatients during nighttime and daytime following childbirth and how this may affect their mental and physical health and wellbeing. If abnormalities are identified, targeted interventions may be possible to optimize recovery following delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum patients | – | Procedure: planned or unplanned Cesarean, operative, or non operative deliveryWomen booked and have delivery of their child(ren) at Lucile Packard Children's Hospital |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All pregnant women booked to deliver their child(ren) at Lucile Packard Children's Hospital. Eligible and consenting patients enrolled will wear an Actigraph watch during their inpatient stay (from preoperative period if undergoing cesarean delivery or during labor if undergoing a planned vaginal delivery).
Key inclusion criteria (4 listed)
- over 18 years old
- live pregnancy
- Single or multiple gestation
- all gestational ages
Key exclusion criteria (8 listed)
- Weekend delivery
- admitted to critical care
- unable to speak or understand English
- known sleeping disorder
- opioid requirement prior to admission
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 |
|---|---|---|
| planned or unplanned Cesarean, operative, or non operative deliveryAll types of delivery | Procedure or surgery | Postpartum patients |
Primary outcome
Assessment of inpatient postpartum sleep using actigraphy
Time frame: During inpatient stay (up to 7 days)
Participants will wear an acitgraphy watch during their inpatient stay to measure sleep.
6 secondary outcomes
Association between actigraphy data with inpatient and outpatient postpartum Patient Reported Outcome Measures (PROMs)
Time frame: Day 1-7, 6 and 12 weeks
Association between inpatient actigraphy data and patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
Time frame: During inpatient stay and outpatient follow up (up to 7 days)
Association between outpatient sleep data with patient demographic, medical, obstetric, psychiatric, neonatal and anesthetic factors
Time frame: 6 and 12 weeks
Association between objective (artigraphy) and subjective sleep assessment using diaries and PROMs
Time frame: Day 1-7, 6 and 12 weeks
Determine population norms of objective and subjective sleep measures in the postpartum population.
Time frame: Day 1-7, 6 and 12 weeks
Association between inpatient sleep and physical activity, PROMs and peripartum course with longer term outpatient sleep measures
Time frame: Day 1-7, 6 and 12 weeks
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 Jun 2023.
- Individual participant dataSharing planned: No. The data collected from the watches will not be available to share with other researchers. Anonymous and aggregated data will be available for verification only on request.
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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.
Pervez Sultan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Stanford University 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 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: finished, as of the sponsor's last update on 6 Jun 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?
Assessment of inpatient postpartum sleep using actigraphy (time frame: During inpatient stay (up to 7 days)). 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 6 Jun 2023.