Protocol Number: 06-DK-0036

Title:

Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

Number:

06-DK-0036

Summary:

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:

-Baseline visit - Month 0 (overnight hospital stay): At the start of the study, participants have blood and urine tests, their sleep, exercise and food diaries are reviewed, and their body measurements are taken. They have various tests that measure their body fat and lean muscle tissue, the rate at which their body burns calories, and their level of physical conditioning. They answer questionnaires about their appetite, sleepiness, mood, anxiety, pain, and health status and are tested for diabetes and daytime sleepiness. Between visits, subjects fill out exercise and sleep diaries, wear the activity watch, record their weight and blood pressure, and wear a pedometer to record a daily count of the steps they take.

-Interim visits - Months 1, 2, 4, 6, 8 and 10: Participants have blood tests and their sleep and exercise diaries, food intake from the previous day, blood pressure and weight measurements, pedometer step records and activity records from the activity watches are reviewed. They are asked about their sleep, mood and anxiety, and they rate their appetite and sleepiness.

-End-point visit - Month 12 (2-day hospital stay): Participants repeat the sleep study and the tests done at the baseline visit. They are given information about a healthy diet, exercise and sleep. They are asked to exercise regularly, eat a healthy balanced diet, continue to wear the pedometer, complete the sleep and exercise diaries for one week of each month, and take monthly weight and blood pressure measurements. Group A subjects are asked to continue sleeping as much as possible up to 7.5 hours a night; group B subjects are given a plan to try to increase their sleep up to 7.5 hours a night.

-Follow-up visit - Month 18 (2-day hospital stay): Participants repeat several, but not all, of the tests and procedures they had at the 0- and 12-month visits, have another sleep study, and review the sleep, exercise, and food diaries for the last 6 months.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

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:

-Chronic insomnia

-Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized criteria for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable).

-Restless leg syndrome or periodic limb movement disorder

-Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence)

-Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night

-Narcolepsy

-Central apnea.

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:

-COPD

-Chronic cardiac arrhythmia requiring treatments

-Gastro-esophageal disorders associated with sleep-related symptoms.

Medications

-chronic use of prescription or over-the-counter medications known to affect sleep (e.g., systemic steroids, NSAIDs)

-current anticonvulsant therapy

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:

-Eating disorders such as bulimia nervosa and binge eating disorder

-Anxiety disorders such as PTSD and panic attacks

-Mania

-Schizophrenia.

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.

Special Instructions:

Currently Not Provided

Keywords:

Sleep Deprivation

Obesity

Metabolic Syndrome

Hormones

Public Health

Recruitment Keyword(s):

Obesity

Overweight

Sleep

Sleep Deprivation

Condition(s):

Obesity

Chronic Sleep Deprivation

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Increase sleep

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Cizza G, Skarulis M, Mignot E. A link between short sleep and obesity: building the evidence for causation. Sleep. 2005 Oct 1;28(10):1217-20. No abstract available.

Cizza G, Romagni P, Lotsikas A, Lam G, Rosenthal NE, Chrousos GP. Plasma leptin in men and women with seasonal affective disorder and in healthy matched controls. Horm Metab Res. 2005 Jan;37(1):45-8.

Bray GA. Medical consequences of obesity. J Clin Endocrinol Metab. 2004 Jun;89(6):2583-9. Review.

Gangwisch JE, Malaspina D, Boden-Albala B, Heymsfield SB. Inadequate sleep as a risk factor for obesity: analyses of the NHANES I. Sleep. 2005 Oct 1;28(10):1289-96.

Hasler G, Buysse DJ, Klaghofer R, Gamma A, Ajdacic V, Eich D, Rossler W, Angst J. The association between short sleep duration and obesity in young adults: a 13-year prospective study. Sleep. 2004 Jun 15;27(4):661-6.

Spiegel K, Tasali E, Penev P, Van Cauter E. Brief communication: Sleep curtailment in healthy young men is associated with decreased leptin levels, elevated ghrelin levels, and increased hunger and appetite. Ann Intern Med. 2004 Dec 7;141(11):846-50. Summary for patients in: Ann Intern Med. 2004 Dec 7;141(11):I52.

Wehr TA. Effect of seasonal changes in daylength on human neuroendocrine function. Horm Res. 1998;49(3-4):118-24. Review.

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