Sleep Disturbance in Hospitalized Antepartum PatientsNCT04485728
Sleep Improvement Intervention for Hospitalized Antepartum Patients
A study testing Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients in people with Sleep Disturbance in Hospitalized Antepartum Patients, run by Sam Houston State University at 1 site in United States.
Trial summary
This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance in Hospitalized Antepartum Patients
- What is being tested?
- Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 31 Jan 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- speak, read, and write English
- medically stable
- 20 weeks' gestation or greater
- viable fetus
- hospitalized at least 24 hours
Who cannot join
- Do not speak, read, and write English
- Medically unstable
- Less than 20 weeks' gestation
- Nonviable fetus
- Hospitalized less than 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
About this study
This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).
- Being tested
- Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Improvement Protocol Intervention for Hospitalized Antepartum PatientsBehavioural
Patients are getting sleep hygiene education and a sleep hygiene kit.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Improvement Intervention | Experimental | Not described Receives: Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients |
| Standard of Care (Control) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who use the sleep improvement intervention
Measured: Day 7
Level of satisfaction with the intervention as assessed by a Likert assessment
The scale ranges from 0-5 with 5 being extremely satisfied
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start11 Mar 2022
- Primary completion31 Jul 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 Sleep Disturbance in Hospitalized Antepartum PatientsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sam Houston State University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, Memorial Hermann Texas Medical Center
- Responsible party
- Principal investigator, Andrea Smith, Sam Houston State University
- Investigators
- Andrea M Smith, Ph.D., RN, Principal investigator, Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485728
- Sponsor's protocol ID
- IRB-2020-83
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Improvement Intervention for Hospitalized Antepartum Patients
- ClinicalTrials.gov ID
- NCT04485728
- Acronym / sponsor ID
- IRB-2020-83
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sam Houston State UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, Memorial Hermann Texas Medical Center
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 24 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.
This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Improvement Intervention | Experimental | Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients |
| Standard of Care (Control) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- speak, read, and write English
- medically stable
- 20 weeks' gestation or greater
- viable fetus
- hospitalized at least 24 hours
Key exclusion criteria (5 listed)
- Do not speak, read, and write English
- Medically unstable
- Less than 20 weeks' gestation
- Nonviable fetus
- Hospitalized less than 24 hours
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 |
|---|---|---|
| Sleep Improvement Protocol Intervention for Hospitalized Antepartum PatientsPatients are getting sleep hygiene education and a sleep hygiene kit. | Behavioural | Sleep Improvement Intervention |
Primary outcome
Number of patients who use the sleep improvement intervention
Time frame: Day 7
Level of satisfaction with the intervention as assessed by a Likert assessment
Time frame: Day 7
The scale ranges from 0-5 with 5 being extremely satisfied
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 2 Aug 2023.
- Individual participant dataSharing planned: No
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.
Andrea M Smith, Ph.D., RN principal investigator
Sam Houston State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients in people with Sleep Disturbance in Hospitalized Antepartum Patients, run by Sam Houston State 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 5 inclusion and 5 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 2 Aug 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 patients who use the sleep improvement intervention (time frame: Day 7). The study lists 2 primary outcomes in all. 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 2 Aug 2023.