DiabetesNCT01739712
Sleep Intervention for Youth With Type 1 Diabetes
A study testing Sleep extension and Fixed Sleep Duration in people with Diabetes, run by University of Arizona at 1 site in United States.
Trial summary
Sleep intervention for youth with diabetes Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Sleep extension and Fixed Sleep Duration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2016
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of type 1 diabetes
- enrolled in school
Who cannot join
- not hospitalized within past month
- neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Angel Wing Clinic for Diabetes
Tucson, Arizona, 85719
About this study
Official title: Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement
Sleep intervention for youth with diabetes
Read the detailed description
It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.
- Conditions
- Diabetes
- Being tested
- Sleep extension, Fixed Sleep Duration
- Keywords
- Diabetes, Sleep problems, School, Neurobehavioral
- Medical subject headings
- Diabetes Mellitus, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extensionBehavioural
There will be a consultation with families to help youth to be successful in extending their sleep.
Fixed Sleep DurationBehavioural
There will be a consultation with families to instruct youth to maintain the same average nightly sleep duration during the modification week. The purpose is to control for time and attention.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension | Experimental | All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer Receives: Behavioral: Sleep extension |
| Fixed Sleep Duration | Sham comparator | All youth in this condition are asked to maintain their baseline sleep duration. Receives: Behavioral: Fixed Sleep Duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic Rating Scale
A teacher behavioral rating of classroom behaviors and performance
Measured: 2 weeks
Glucose control
Continuous glucose monitor
Measured: 2 weeks
Neurocognitive performance
Cogstate learning and memory tasks
Measured: 2 weeks
Academic performance
Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Perfect, University of Arizona
- Investigators
- Michelle M Perfect, PhD, Principal investigator, UA College of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739712
- Sponsor's protocol ID
- 12-0733091
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2012
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Upon request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement
- ClinicalTrials.gov ID
- NCT01739712
- Acronym / sponsor ID
- 12-0733091
- Conditions
- Diabetes
- Keywords
- Diabetes, Sleep problems, School, Neurobehavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Dec 2012 (estimated)
- 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 intervention for youth with diabetes
Detailed description
It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: Sleep extensionAll youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer |
| Fixed Sleep Duration | Sham comparator | Behavioral: Fixed Sleep DurationAll youth in this condition are asked to maintain their baseline sleep duration. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of type 1 diabetes
- enrolled in school
Key exclusion criteria (2 listed)
- not hospitalized within past month
- neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation
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 extensionThere will be a consultation with families to help youth to be successful in extending their sleep. | Behavioural | Sleep Extension |
| Fixed Sleep DurationThere will be a consultation with families to instruct youth to maintain the same average nightly sleep duration during the modification week. The purpose is to control for time and attention. | Behavioural | Fixed Sleep Duration |
Primary outcome
Academic Rating Scale
Time frame: 2 weeks
A teacher behavioral rating of classroom behaviors and performance
Glucose control
Time frame: 2 weeks
Continuous glucose monitor
Neurocognitive performance
Time frame: 2 weeks
Cogstate learning and memory tasks
Academic performance
Time frame: 2 weeks
Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements
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 21 Nov 2016.
- Individual participant dataSharing planned: Yes. Upon 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.
Michelle M Perfect, PhD principal investigator
UA College of Education
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 extension and Fixed Sleep Duration in people with Diabetes, run by University of Arizona 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 2 inclusion and 2 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 21 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Academic Rating Scale (time frame: 2 weeks). The study lists 4 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 21 Nov 2016.