Effects of exercise and diet interventions on obesity-related sleep disorders: a randomized controlled trial in men

Finnish Funding Agency for Technology and Innovation (TEKES)0 sites45 target enrollmentOctober 23, 2012

Overview

Registry

who.int

Start Date

October 23, 2012

End Date

December 31, 2013

Last Updated

5 years ago

Study Type

Interventional

Sex

Male

Sponsor

Finnish Funding Agency for Technology and Innovation (TEKES)

•Current inclusion criteria as of 25/02/2013:
•Apnea and insomnia patient groups:
•1\. Men in an age range of 30 to 65 years
•2\. Occasionally physically active or sedentary (regular leisure\-time exercise \= 2 times/wk \& \= 45 min/time)
•3\. Reports recurrent difficulty in falling asleep, too short sleep duration or poor quality of sleep during past 2 months. Or with mild to moderate OSA (AHI 5\-30 / hour), with or without continuous positive airway pressure (CPAP) treatment. If under treatment, nasal CPAP for a minimum period of 6 months prior the baseline measurements, with a minimum adherence to CPAP therapy for 4 hours per night
•4\. Relatively healthy (free from cardiovascular comorbidities)
•Reference (healthy men) group:
•1\. Men in an age range of 30 to 65 years
•2\. No chronic sleep disorders and medications related to sleep disorders
•3\. No disease and medications during past 1 year

•Current exclusion criteria as of 25/02/2013:
•1\. Diseases and medications related to insulin dependent diabetes mellitus, Crohn?s disease, sarcoidosis, celiac disease, thyroid, liver and severe heart diseases, chronic diarrhea, ulcerative colitis, rheumatoid arthritis, severe osteoarthritis, systemic lupus erythematous, cancer during past 3 years.
•2\. Currently taking special diet (such as very low calorie diet)
•3\. Other diagnosed sleep disorders (such as narcolepsy)
•4\. Shift workers (working during night)
•5\. Reported cognitive impairment
•6\. Using antibiotics during the previous 3 months
•7\. History of eating disorders
•8\. Subjects using CPAP, professional drivers and other professions that are at risk for accident due to discontinuation in CPAP treatment
•9\. Not suitable for the study by a physician?s evaluation