Monitoring and treatment of obesity-related sleep disorders

Not Applicable

Completed

• Conditions: Sleep disorders, Insomnia, Obstructive sleep apnoea; Nervous System Diseases; Sleep apnoea

• Registration Number: ISRCTN77172005
• Lead Sponsor: Finnish Funding Agency for Technology and Innovation (TEKES)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23886347 2016 results in https://pubmed.ncbi.nlm.nih.gov/27823703/ (added 19/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-23
• Study Completion: 2013-12-31
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified