Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05747105
Status:
WITHDRAWN
Last Update Posted:
2023-05-19
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Sleep Extension Pilot Study in Adults With Obesity
Sponsor:
University of Pennsylvania
Organization:
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WITHDRAWN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 (\<6.5 hours per night) is a risk factor for poorer health outcomes,1 including overweight and obesity,2 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 sizes.3 Short sleep duration is also related to cardiovascular risk factors, including hypertension.4 Sleep extension studies provide some evidence that increasing time spent asleep at night may improve weight, eating behaviors (e.g., net reduction of 270 kcal/d and 0.87 kg over 4 weeks5), and cardiovascular outcomes (e.g., blood pressure6); however, the current literature is limited by short-term intervention and study periods (e.g., 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 kg/m2). 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:
False
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?: