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

Trial ID or NCT#

NCT01135342

Status

not recruiting iconNOT RECRUITING

Purpose

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:
  2. * 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:
    1. * 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):
    2. * 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.
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Investigator(s)

Christopher Gardner

Contact us to find out if this trial is right for you.

Contact

Antonella Dewell
6507368577

View on ClinicalTrials.gov