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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - 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 Criteria:
  1. 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.


Christopher Gardner

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Antonella Dewell