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Christopher Gardner

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Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss

Contact Information

Central Contact:

Antonella Dewell (650) 736-8577
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Antonella Dewell (650) 736-8577
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.

Stanford Recruiting Status:

 Completed

Condition(s):

Lead Sponsor:

 Stanford University

Intervention(s):

  • Behavior: Weight Loss Regimen and Sleep Cognitive Behavioral Therapy

Phase:

Phase 2

Eligibility

Health of Volunteers:

People with the conditions listed in this trial can not participate as controls.

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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