AzTrials
AzTrials

ObesityNCT05747105

A Sleep Extension Pilot Study in Adults With Obesity

A study testing Sleep Extension in people with Obesity and Sleep, run by University of Pennsylvania at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obesity, Sleep, Weight, Body
What is being tested?
Sleep Extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
7 Feb 2023to Jan 2024
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults, aged 18-50 years old,
  • All genders
  • Body Mass Index within the obese weight status (BMI of ≥ 30 kg/m2)
  • Short sleep duration, defined as sleeping, on average, <6.5 hours/night for at least 5 nights/week
  • Sleep patterns must be stable for the past 6 months
  • Weight must be stable (+/- 10 lb) for the past 6 months
Show all 9Show fewer
  • If taking medication for medical or mental health conditions, the condition must be well-controlled with stable dosage (i.e., at least 3 months)
  • Note: Individuals with and without insomnia will be eligible to participate to increase generalizability of the findings. Also, individuals with known obstructive sleep apnea that is being treated and individuals who fall below the "very high risk" category for obstructive sleep apnea (on the ARES screening questionnaire) will be included.
  • Participants must provide a completed form for study participation from their primary care provider to confirm that it is safe from a medical perspective

Who cannot join

  • Specific chronic sleep disorders (e.g., untreated or at very high risk for obstructive sleep apnea, restless leg syndrome, parasomnias, narcolepsy, central apnea, chronic fatigue syndrome, or fibromyalgia)
  • Extreme chronotype (i.e., extreme morning or evening sleep patterns)
  • Work schedule that is not compatible with sleep habit changes (e.g., night shifts, rotating shift work, or long driving)
  • Chronic use of sleep aid or anticonvulsant medications
  • Chronic organ disorders (e.g., untreated or uncontrolled diabetes, other endocrine disorders, COPD, chronic cardiac arrhythmia, uncontrolled hypertension or gastro-esophageal disorders)
  • Current enrollment in a weight loss program or any active weight loss attempt (e.g., self-directed diet/exercise, over-the-counter supplements, weight management medication)
Show all 15Show fewer
  • History of bariatric surgery (with the exception of an adjustable gastric band that has been removed)
  • Mental health disorders judged severe (e.g., major depression, eating disorders, anxiety disorders, bipolar disorder/mania, schizophrenia, active suicidal ideation)
  • Substance use (e.g., illicit drugs, marijuana dependence, excessive caffeine intake, smoking/tobacco use)
  • Planned move outside of the Philadelphia area in the next 6 months
  • Planned travel across time zones during the study period
  • Family factors that may interfere with adherence to the study protocol (e.g., infants and young children that consistently disrupt their sleep schedule; partner, other individuals, or pets that would make compliance difficult)
  • Pregnancy or lactation or plans to become pregnant during the study period
  • Menopause
  • Any other contraindication to participation as determined by the study team

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A 16-Week Sleep Extension Pilot Study in Adults With Obesity

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 .

Read the 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.

Being tested
Sleep Extension
Keywords
short sleep duration, sleep extension, obesity, eating behavior, blood pressure
Medical subject headings
Obesity, Body Weight, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep ExtensionBehavioural

    The 16-week protocol includes 11 total individual visits that integrate applicable elements of Cognitive Behavioral Therapy for Insomnia (CBT-I) and health behavior change theory. The first 6 weeks include weekly sessions (~45 minutes each) focused on psychoeducation about sleep, goal-setting and self-monitoring, stimulus control, addressing cognitive and somatic arousal, sleep hygiene, and challenging negative thoughts about sleep. Sleep restriction will also be used in specific cases where sleep efficiency is low (<85%). The remaining 10 weeks include briefer biweekly visits (5 visits, ~15-20 minutes each) to reinforce health behavior change strategies through topics such as problem-solving barriers, utilizing social support, identifying setbacks and creating an action plan, and relapse prevention. Self-reported sleep diary data and subjective sleepiness will be collected at each visit.

Study groups in NCT05747105
Study groupRoleWhat they receive
Sleep Extension InterventionExperimentalAll participants will receive the 16-week sleep extension intervention aimed to lengthen nighttime sleep duration by at least 30-60 minutes per night. No prescription for daily calorie/dietary intake or physical activity will be provided in this study, except behaviors consistent with sleep hygiene recommendations.
Receives: Behavioral: Sleep Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of intervention session attendance

    The percentage of sessions attended by participants across the 16-week intervention

    Measured: Baseline to Week 16 of the intervention

  2. Percentage of participants who complete the study

    The percentage of participants who complete the final Week 16 visit

    Measured: Baseline to Week 16 of the intervention

Secondary outcomes (2)

  1. Change in nighttime sleep duration

    Average nighttime sleep duration as measured by actigraphy during a 1-week monitoring period

    Measured: Baseline to Week 16 of the intervention

  2. Change in weight

    Weight as measured in kilograms

    Measured: Baseline to Week 16 of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start7 Feb 2023
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Unable to move forward with the study due to personnel changes

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a single-arm pilot intervention study to assess the efficacy of a 16-week sleep extension protocol.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05747105
Sponsor's protocol ID
852866
Status last verified
May 2023
First submitted
6 Feb 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Extension in people with Obesity and Sleep, run by University of Pennsylvania 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 9 inclusion and 15 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: withdrawn, as of the sponsor's last update on 19 May 2023. 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

Percentage of intervention session attendance (time frame: Baseline to Week 16 of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05747105.

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 19 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in