Status:
COMPLETED
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Initiation and Maintenance Disorders
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
Detailed Description
The major purpose of this study is to examine the effect of sleep quality and quantity on weight loss. The outcomes being studied are weight loss and improved sleep. The subjects being studied are tho...
Eligibility Criteria
Inclusion
- Gender: Both women and men
- Age: \> or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- The following, which will be measured at the screening clinic visit:
- Body Mass Index: 28-40 (kg/m-squared)
- Chronic Short Sleep: total sleep time \< 6.5 hours, greater than or equal to 4 days per week (determined by 1-week sleep log) for the past 6 months or longer (based on self-report).
- Insomnia: sleep latency and/or wake after sleep onset \> 30 minutes, greater than or equal to 4 days per week, insomnia severity index \> 10, and complaint of at least one negative effect during waking hours (such as fatigue, sleepiness, impaired functioning, mood disturbance) attributed to sleep (as determined by self report).
- Eligible sleep disorder: sleep apnea or upper airway resistance syndrome treated by positive airway therapy for \> or = 3 months resulting in improved sleep.
- Psychiatric disorders that are stable on SSRI, SNRI, or bupropion antidepressant for greater than or equal to 3 months if no anticipated changes in medications to occur during the trial if they are weight stable.
- Planning to be available for clinic visits and for the 8 weeks of study participation
- Ability and willingness to give written informed consent.
Exclusion
- At screening:
- Sleep apnea (apnea-hypopnea index \> 15/hr) determined by portable sleep diagnostic system Periodic limb movements during sleep (PLM with arousal index \> 15/hr) determined by polysomnography.
- Any suspected sleep disorders identified by the Global Sleep Assessment Questionnaire, including circadian rhythm disorders (including shift work), parasomnias, narcolepsy, and restless leg.
- Self reported personal history of:
- DSM-IV Axis-I and Axis-II diagnoses (i.e. eating disorders, bi-polar disorder, schizophrenia and other psychotic disorders, substance-related disorders, personality disorders, poorly controlled major depression and anxiety disorders determined by SCID) except those allowed under Inclusions.
- Subjects currently receiving the following medications known to affect sleep(self report):
- sedative hypnotics
- sedative antidepressants
- systemic steroids
- anticonvulsants
- histamine-1
- receptor antagonists
- narcotic analgesics
- CNS stimulants
- Body Mass Index (BMI) greater than 40.
- Pregnant, Lactating, or \<6 months post-partum.
- Inability to communicate effectively with study personnel.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01135342
Start Date
July 1 2009
End Date
March 1 2010
Last Update
February 22 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305