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.

Lead Sponsor:

Stanford University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Diet and exercise
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Passion and Balance

Phase:

N/A

Eligibility


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.

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 - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Antonella Dewell
6507368577