Trial Search Results
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
Stanford is currently not accepting patients for this trial.
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
- Behavioral: Diet and exercise
- Behavioral: Cognitive Behavioral Therapy
- Behavioral: Passion and Balance
- 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
- 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
- Ability and willingness to give written informed consent.
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
- sedative hypnotics
- sedative antidepressants
- systemic steroids
- 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 - N/A
Genders Eligible for Study