Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-01
Brief Title:
Settling Down for Sleep in ADHD the Impact of Sensory and Arousal Systems on Sleep in ADHD
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Settling Down for Sleep the Impact of Sensory and Arousal Systems on Sleep in ADHD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is test the hypothesis that sleep problems for children with ADHD are linked to sensory over-responsivity a type of sensory processing difference that causes a person to interpret daily sensory input as stressful This study examines the impact of sensory over-responsivity on bedtime arousal levels in 30 children with ADHD ages 6-10 We will also test a bedtime intervention targeting sensory over-responsivity at bedtime and examine how it impacts bedtime arousal levels and sleep difficulties
Detailed Description:
Following the consent process baseline data collection will be completed electronically with questionnaires sent digitally to participants parent and child using a secure web-based application REDCap Participants will then complete a virtual clinical baseline interview and training on the wear of the EmbracePlus watch and the daily virtual sleep diary Upon completion of this the study team will then send the watch and its accessories to the participant via the mail
Time point 1 home-based data collection 1 week Once the caregiver and child receive the watch and study materials home-based data collection will start During this 1-week period the child will wear the watch 24-hoursday for one week and the caregivers will complete daily sleep diary entries morning and evening At the end of this data collection period the study materials will be brought into the lab session
Lab-based session 1-2 hours Participants and caregivers will complete a training session on the environmental changes and a novel bedtime manipulation intervention called the Power Down
Time point 2 home-based data collection 1 week Participants will apply any sleep environment changes identified during the lab session complete the power down each night child will wear the watch 24hrsday and caregivers will complete daily sleep diaries morning and evening At the end of this week all study materials will be mailed back to the study team and a virtual exit interview will be completed Final sleep and intervention acceptability questionnaires will be completed virtually
Time point 1 home-based data collection 1 week Once the caregiver and child receive the watch and study materials home-based data collection will start During this 1-week period the child will wear the watch 24-hoursday for one week and the caregivers will complete daily sleep diary entries morning and evening At the end of this data collection period the study materials will be brought into the lab session
Lab-based session 1-2 hours Participants and caregivers will complete a training session on the environmental changes and a novel bedtime manipulation intervention called the Power Down
Time point 2 home-based data collection 1 week Participants will apply any sleep environment changes identified during the lab session complete the power down each night child will wear the watch 24hrsday and caregivers will complete daily sleep diaries morning and evening At the end of this week all study materials will be mailed back to the study team and a virtual exit interview will be completed Final sleep and intervention acceptability questionnaires will be completed virtually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None