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
Not Recruiting