SleepNCT04202731
Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
A study testing PBS Study in people with Sleep, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- PBS Study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 14 Jul 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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ages 12-21 years
- attending high school or middle school (peak period for insufficient and delayed sleep)
- completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
- All must also be Tanner Stage 5
Who cannot join
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
- HbA1c ≥6.5%
- intelligence quotient (IQ) <70 or severe mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.
- Conditions
- Sleep
- Being tested
- PBS Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBS StudyBehavioural
Sleep extension intervention
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension | Experimental | Participants will be asked to extend their time in bed with the goal of improving the total time they sleep each night. Receives: Behavioral: PBS Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Total sleep time at night in hours
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start20 Nov 2019
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Why it stopped: COVID-19 pandemic impacted recruitment
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 University of Colorado, DenverThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill L Kaar, PhD, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202731
- Sponsor's protocol ID
- 19-0926
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2019
- Last updated
- 27 Jul 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
- ClinicalTrials.gov ID
- NCT04202731
- Acronym / sponsor ID
- 19-0926
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic impacted recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 18 Dec 2019 (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.
Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: PBS StudyParticipants will be asked to extend their time in bed with the goal of improving the total time they sleep each night. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- ages 12-21 years
- attending high school or middle school (peak period for insufficient and delayed sleep)
- completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
- All must also be Tanner Stage 5
Key exclusion criteria (3 listed)
- regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
- HbA1c ≥6.5%
- intelligence quotient (IQ) <70 or severe mental illness
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 |
|---|---|---|
| PBS StudySleep extension intervention | Behavioural | Sleep Extension |
Primary outcome
Sleep duration
Time frame: 1 week
Total sleep time at night in hours
Results and safety
The study was stopped early (reason given: COVID-19 pandemic impacted recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Jill L Kaar, PhD principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBS Study in people with Sleep, run by University of Colorado, Denver 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 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: stopped early, as of the sponsor's last update on 27 Jul 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 was stopped early (reason given: COVID-19 pandemic impacted recruitment). Results are not available in the source record.
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?
Sleep duration (time frame: 1 week). 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 27 Jul 2023.