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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00261898 |
This study will test whether people can change the number of hours they sleep at night and if such an increase in sleep affects their body weight. It will examine whether the number of hours of sleep relate to body weight, the amount of body fat and the level of hormones that help to control appetite.
People between 18 and 50 years of age who sleep less than 6 hours at night and who are obese may be eligible for this study. Each candidate is screened with a medical history and physical examination, psychological interview, blood and urine tests, electrocardiogram and questionnaire about sleep, mood, physical activity and level of sleepiness and appetite. For two weeks, participants will keep sleep and exercise diaries and wear a wrist device (activity watch) that measures how much they move around throughout the day and night. They keep a food diary for three days and then are admitted to the hospital for a sleep study. For this test, electrodes are attached to the subject's chest, chin, scalp and skin near the eyes. A band is placed around the chest, a small device is placed near a nostril, and a clip is placed on the index finger. These devices are used to record information about breathing, sleep stages, electrical activity in the brain and heart, and blood oxygen levels. A video camera records the subject's movements.
Participants are randomly assigned to one of two groups. Over the 12-month study, group A subjects increase their amount of night-time sleep up to a limit of 7.5 hours a night; group B subjects continue to sleep the same amount they have been sleeping in the past 6 months. Plans are devised for group A to increase their sleep time and for group B to continue getting the same amount of sleep they have in the past. All subjects undergo the following tests and procedures:
Condition | Intervention | Phase |
---|---|---|
Obesity Chronic Sleep Deprivation |
Procedure: Increase sleep |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity |
Estimated Enrollment: | 450 |
Study Start Date: | November 2005 |
OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive medical problems in recent years. The prevalence of adult obesity has doubled over the past 30 years and continues to increase. In addition, industrial societies attach an economic value to maximizing the waking period to the longest tolerable limit by sleeping as little as possible. Average sleep time has decreased over the last century by 2 hours. Chronically sleeping less has been associated with increased weight, endocrine and metabolic health risks including glucose intolerance, cardiovascular disease, and mortality. The possibility that the current epidemic of obesity and metabolic health risks may be partially related to insufficient sleep is now being recognized. The objective of this proof-of-concept controlled trial is to investigate the impact of increasing sleep time in chronically sleep-deprived, obese subjects.
STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep deprivation will be verified by the use of sleep logs and the use of actigraphy before entry into the study. Secondary causes of sleep deprivation such as insomnia, psychological (depression), and medical conditions associated with poor sleep quality (including obstructive sleep apnea) will be exclusionary criteria.
DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological fashion. The main analysis of the study will be to determine if additional sleep will result in a significant difference in body weight at the end of 12 months between the Intervention Group and the Comparison Group. In addition, we would like to establish whether 12 months of additional sleep will result in: a) a decreased prevalence of metabolic syndrome; and b) changes in the endocrine profile (i.e. inducing changes in leptin [increase] and ghrelin [decrease] opposite to the changes associated with chronic sleep deprivation). At the end of the 12-month intervention study (Phase 1, Efficacy Randomized Phase Study), all participants will be given information about the potential benefit of more sleep and encouraged to increase sleep time. Health teaching about proper nutrition and adequate exercise will also be provided at that time to the Intervention and Comparison Groups. All participants will be evaluated 6 months later to assess the effects of this intervention in a real-life situation, and offered participation in a three-year extension with semi-annual visits (Phase 2, Effectiveness 3 Year Follow-Up Phase Study), for which matched external comparison subjects will also be recruited ad hoc.
OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine and anthropometric measures, body composition, various metabolic parameters, food intake, energy expenditure, and quality of life measures.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
18 to 50 year old obese men and premenopausal women
BMI between 29-55
Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs).
INCLUSION CRITERIA: External comparison subjects for extension of Effectiveness Study must meet the criteria above.
EXCLUSION CRITERIA:
Diagnosed sleep disorders including:
Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program
Untreated or uncontrolled diabetes
Severe uncontrolled hypertension
Other chronic organ disease diagnosis including:
Medications
Chronic fatigue syndrome and fibromyalgia
Acromegaly, hypothyroidism (unless on a stable replacement dose of thyroid hormone), Cushing disease or other endocrine disorders known to affect sleep
Poorly controlled major depression (subjects who have been on a stable pharmacological antidepressant treatment for 3 months and are in remission without substantial weight gain are eligible).
Other current DSM-IV diagnoses, including:
Medication and substance abuse such as excessive alcohol consumption or drug abuse or dependence that may pose a threat to compliance
Being a rotating worker, shift worker (working evenings or nights), or long distance commuter (more than approximately 90 minutes each way), traveling frequently outside of time zone; being in an occupation that may require special vigilance such as driving a truck, bus, or cab; operating heavy machinery; being a pilot or air traffic controller
Being likely to move to a different geographical area during the study
Having a sleep partner that would make compliance with study requirements difficult
Pregnancy and lactation
Menopause
Chronic excessive caffeine use (habitual intake of more than 500 mg/day)
Any condition that in the opinion of the principal investigator makes study participation and compliance problematic.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 060036, 06-DK-0036 |
Study First Received: | December 4, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00261898 |
Health Authority: | United States: Federal Government |
Sleep Deprivation Obesity Metabolic Syndrome Hormones Public Health |
Obesity Overweight Sleep Sleep Deprivation |
Body Weight Signs and Symptoms Obesity Mental Disorders Neurologic Manifestations Sleep Disorders |
Dyssomnias Nutrition Disorders Overnutrition Overweight Sleep Deprivation |
Pathologic Processes Disease Syndrome Nervous System Diseases |