Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this pilot clinical trial is to determine the feasibility and acceptability of increasing time in bed to 10 hours per night in children aged 14-17 years. The main question it aims to answer are:
Researchers will compare the control group to the 10 hour time in bed group to see if it is feasible for 14-17 year olds to be in bed for that long and wear two devices.
We are conducting this research study to determine if it is feasible to have teenagers devote more time to being in bed for sleep. Specifically, we will try to determine how much more teens sleep when spending 10 hours in bed for a week. If after it is determined from a phone screen that the child is eligible, they will be asked to come into our Center for an Orientation.
During this visit, we will explain the research study to participants and families in more detail. Families that enroll will visit the Center one more time at the end of the study. During the orientation visit, we will determine the child's final eligibility based on how much he/she sleeps and a measurement of the child's height and weight. If eligible and interested in participating, the child would wear two devices -one that measures sleep and one that measures activity - and keep a sleep diary for a week. During this week, the child would also call/text our Center twice each day to report on his/her bedtime and wake time. The second visit to the center occurs at the end of that week.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Sleep Condition Group | No Intervention | This group will not partake in the intervention, they will sleep the normal amount that they do on a regular basis. Participants will wear a hip physical activity monitor and a wrist actigraph to measure sleep. | |
| 10-hour Time in Bed Group | Experimental | This group will partake in the intervention of increasing time in bed to 10 hours per night. Participants will wear a hip physical activity monitor and a wrist actigraph to measure sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10-hour Time in Bed | Behavioral | Participants will be asked to increase their time in bed to 10-hours per night for 7 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability of Increasing Time in Bed to 10 hours per Night in Adolescents | An acceptability and feasibility questionnaire will be administered to participants at a follow up visit to measure the difficulty of increasing time in bed to 10 hours per night and wearing the two devices given. This questionnaire serves as feedback for the principal investigator to measure the feasibility of adolescents increasing time in bed to 10 hours per night and wearing two devices. Roughly half the questions are open ended and gauge the participants' physical experience during the study. The other half are scored 0-4 and ask about the participants' increase or decrease in school performance, overall mental health status, and physical health status during the day. For the questions that rank 0-4, a 0 indicates that specific aspect became a lot worse since the study, and a 4 indicates it became a lot better, or it increased over the course of the study. | The questionnaire will take approximately 5-10 minutes. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taylor McCoy, B.S. | Contact | 732-554-1532 | tm953@kines.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Spaeth, Ph.D | Associate Professor, Lab Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Sleep Lab | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Luginbuehl M B-KK, Ferron J, Anderson WM, Benbadis SR. Pediatric sleep disorders: Validation of the SleepDisorders Inventory for Students. . School Psychol Rev. 2008; 37(3):409-31. | ||
| Background | Actigraph Data Collection, Proofing, and Scoring Procedures AW2 2018 | ||
| 23700330 | Background | Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22. |
| Label | URL |
|---|---|
| Sleep Disorders Inventory for Students | View source |
Not provided
All individual participant data that will be collected will be shared with other researchers, after deidentification.
Immediately following publication.
Anyone who wishes to access the data can do so.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2022 | Jan 17, 2023 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013995 | Time |
| D001513 | Beds |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Participants will be assigned to either a control group or an increased time in bed (10 hours/night) group.
Not provided
Not provided
Not provided
Not provided