Improvement of sleep-disordered breathing in patients with sleep apnea Nervous System Diseases
Conditions
Interventions
The participants were randomly assigned to a group using a randomization algorithm. Using a hierarchical structure, the algorithm prioritized balancing the female and male count across the three group
Sponsors
Horizon 2020 - European Union
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed, informed, written consent 2. Age 18 - 50 years 3. Verified mild to moderate sleep-disordered-breathing according to the current American Academy of Sleep Medicine and International Classification of Sleep Disorders criteria 4. The SDB level may range from habitual snoring to positional and mild obstructive sleep apnea, not fulfilling the criteria for continuous positive airway pressure therapy treatment 5. BMI =25 kg/m2 (overweight or obese) 6. Inactive person (no participation in exercise programs at baseline) 7. Subjects willing to try lifestyle change, including an exercise program 8. Willingness to perform the study-specific testing both at baseline and during follow-up 9. Ability to read, follow the lifestyle program and answer the questionnaires in DMP, electronic sleep diary and objective daytime testing (via DMP and physical visits)
Exclusion criteria
Exclusion criteria: 1. Severe OSA 2. Inability to perform an exercise 3. Regular use of hypnotic medications 4. Clinically verified dominant central sleep apnea 5. Known history of active malignant disease 6. Blindness or hearing loss 7. Unstable cardiometabolic disease 8. Unstable psychiatric disease 9. Ongoing alcohol or drug abuse 10. Other medical conditions which may interfere with the study protocol in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDB severity is measured with a three-night sleep study, using self-applied somnography (SAS) from NOX Medical (Reykjavik, Iceland) at baseline and follow-up (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep quality measured objectively with SAS and subjectively with a sleep diary. Objective measures of sleep quality at baseline and 12-week follow-up. Subjective measures of sleep quality daily for the 12-week intervention. 2. Body composition at baseline and 12-week follow-up: 2.1. Body mass index. BMI is a person's weight in kilograms divided by the square of height in meters. 2.2. Body fat percentage. Bioelectrical impedance analysis (BIA) will be used to estimate body composition. In BIA, a weak electric current flows through the body and the voltage is measured in order to calculate the impedance (resistance) of the body. The equipment used will be the Bodystat 500 (Isle of Man, UK). It uses 4 electrodes (ankle and wrist) to measure raw data at any segment of the body. Waist-hip ratio. The waist-to-hip ratio is the ratio of waist circumference to hip circumference, a simple calculation of the measurements of the waist girth divided by the hip girth. 3. Physical fitness at baseline and 12-week follow up: 3.1. Strength. Hand dynamometry of the dominant hand will be was evaluated with a Vernier hand dynamometer (Vernier, Orlando, FL, USA), with the subject seated and the elbow at 90°. 3.2. Cardiorespiratory endurance. The 6-Minute Walking Test is a sub-maximal self-paced test that measures the individual´s sub-maximal capacity to perform activities. The 6-Minute Walking Test measures how far an individual can walk when walking as fast as he/she possibly can in a period of six minutes on a hard and flat surface. The 6-Minute Walking Test is performed indoors on a walking course of 30 meters (60-meter lap). 4. Physiological parameters measured via Withing smartwatch (including SaO2 measurements for SDB severity estimation, movements and pulse) continuously for the 12-week intervention. 5. Neurocognitive function measured using the Rey Auditory Verbal Learning Test (RAVL-T) wordlists, the Wechsler Memory Scale, the Verbal Fluency Test, Digit span, Trail making te | — |
Countries
Iceland
Outcome results
None listed