Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747105
Status:
WITHDRAWN
Last Update Posted:
2023-05-19
First Post:
2023-02-06
Brief Title:
A Sleep Extension Pilot Study in Adults With Obesity
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A 16-Week Sleep Extension Pilot Study in Adults With Obesity
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to move forward with the study due to personnel changes
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pilot study will test the feasibility of a 16-week sleep extension intervention in adults with obesity to increase nighttime sleep duration as well as reduce daytime sleepiness and sleep-related disturbance The study will also examine changes in weight eating behaviors wellbeing and blood pressure across the 16-week intervention
Detailed Description:
Short sleep duration 65 hours per night is a risk factor for poorer health outcomes1 including overweight and obesity2 likely due in part to its impact on energy intake and eating behaviors Previous research with experimental sleep restriction and observational studies of short sleepers has shown that short sleep duration is associated with higher calorie intake including greater calories from fat increased hunger ratings a greater number of daily eating occasions and consumption of larger food portion sizes3 Short sleep duration is also related to cardiovascular risk factors including hypertension4 Sleep extension studies provide some evidence that increasing time spent asleep at night may improve weight eating behaviors eg net reduction of 270 kcald and 087 kg over 4 weeks5 and cardiovascular outcomes eg blood pressure6 however the current literature is limited by short-term intervention and study periods eg 2 to 9 weeks Therefore it is unclear if the effects of sleep extension can be sustained over time and if a longer intervention can produce clinically meaningful weight reduction and associated health improvements in adults with obesity This pilot study will determine the feasibility of a longer 16-week sleep extension intervention to increase nighttime sleep duration among 10 adults aged 18-50 years old with obesity BMI 30 kgm2 Additional secondary outcomes of changes in weight eating behaviors wellbeing and blood pressure will also be assessed If results are positive the protocol will be used to secure external funding for a larger randomized clinical trial
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