Sleep disorders, Insomnia, Obstructive sleep apnoea Nervous System Diseases Sleep apnoea
Conditions
Interventions
6-month exercise or diet intervention is involved in this study.
Exercise program
Based on the fitness test result an individual progressive exercise program is create
Sponsors
Finnish Funding Agency for Technology and Innovation (TEKES)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 4. Relatively healthy (free from cardiovascular comorbidities) Previous inclusion criteria until 25/02/2013: 1. Males with an age range of 30 to 65 years 2. Occasionally physically active or sedentary (regular exercise = 2 times/wk& = 45 min/time) 3. Reported recurrent difficulty in falling asleep, too short sleep time or poor quality of sleep during past 2 months, or diagnosed with Mild to moderate obstructive sleep apnea (AHI 5-30 / hour), with or without CPAP treatment. If under treatment, nasal CPAP for a minimum period of 6 months, with a minimum adherence to CPAP therapy for 4 hours per night. 4. Relatively healthy (free from cardiovascular comorbidities)
Exclusion criteria
Exclusion criteria: 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 Previous exclusion criteria until 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. Diet with very low calorie (VLCD) 3. Other sleep disorders e.g. 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. In patients under CPAP treatment, professional drivers and other professions that are at risk for accident due to discontinuation of CPAP treatment 9. Not suitable for the study by a physician?s evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 25/02/2013: 1. Duration and proportion of sleep stages, heart rate, heart rate variability, respiration and body movements during sleep apnea-hypopnea index [PSG for participants with OSA, Pressure sensor measurement for both OSA and other participants] 2. Subjective measures of duration and quality of sleep (Nordic sleep disorder questionnaire, Epworth Sleepiness Scale, 7-day sleep diary) 3. Lifestyle risk clusters related to sleep disorders (healthy vs. sleep disorder patients) Previous primary outcome measures until 25/02/2013: 1. Subjective quality of sleep (sleep questionnaires including Nordic sleep questionnaire and Epworth Sleepiness Scale, 7-day sleep diary) 2. Sleep architecture, Heart rate, Heart rate variability, Respiratory and Body movements during sleep (polysomnography for subjects with sleep apnea, pressure sensors for subjects with sleep apnea and poor quality of sleep) 3. Both measurements are taken at baseline and after 6-month intervention. In addition, subjective quality of sleep is collected at 3-month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/02/2013: 1. Anthropometry (Body weight and height; Waist, Hip, Chest and Neck circumferences) 2. Blood pressure 3. Body composition (Dual-energy x-ray absorptiometry and Bioimpedance) 4. Fitness (2 km walking test, three-minute step test) 5. Composition of the gut microbes (fecal sample) 6. Subcutaneous adipose tissue metabolism (total RNA) 7. Venous blood samples (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, glucose, insulin, histamine, tryptophan, melatonin, cortisol, adrenalin, leptin, adiponectin, neuroactive steroids, fatty acid, B vitamins, fatty acid profile, as well as inflammatory variables such as CRP, IL-6, and TNF-alpha). Previous secondary outcome measures until 25/02/2013: 1. Venous blood samples (total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, apolipoproteins A-I and B, lipoprotein(a), glucose, insulin, melatonin, serotonin, cortisol, adrenin, leptin, adiponectin, fatty acid profile as well as inflammatory variables i.e., C-reactive protein, TNF? and IL-6, etc.) 2. Blood pressure 3. Body composition (dual-energy x-ray absorptiometry and bioimpedance) 4. Anthropometry (body weight; waist, hip, chest and neck circumference) 5. Fitness (2 km walking test, 3 minute step test) 6. Physical activity (3 day diary) 7. Diet (3 day diary) 8. Fecal samples (composition of the gut microbes) 9. Subcutaneous adipose tissue samples (total RNA, reverse transcription reaction followed by real-time PCR with gene-specific primer sequences) 10. Measurements are taken at baseline, 3-month and after 6-month intervention | — |
Countries
Finland
Outcome results
None listed