Obstructive sleep apnoea syndrome Nervous System Diseases Sleep disorders
Conditions
Interventions
Subjects will be randomly assigned to a VLCD treatment (intervention) or a control group (waiting list).
During 9 weeks the patients allocated to the intervention group will follow a VLCD-programme
Sponsors
Cambridge Manufacturing Company Limited (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Amended as of 09/06/2009: The following points of the below inclusion criteria have been amended: 1. Patients with OSAS with an Apnoea-Hypopnea Index (AHI) greater than or equal to 15 3. Aged between 30 and 65 years All other inclusion criteria remain unaffected. Initial information at time of registration: 1. Patients with OSAS with an Apnoea-Hypopnea Index (AHI) between 15 and 60 2. Male patients 3. Age between 30 and 60 years 4. Abdominal obesity with a Body Mass Index (BMI) 30-40 kg/m^2 and waist circumference >102 cm 5. Signed informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Contraindications for VLCD: 1.1. Coronary thrombosis or myocardial infarct within the last three months 1.2. Cerebro-vascular accident within the last three months 1.3. Unstable ventricular arrhythmias 1.4. Major surgery or trauma within the last three months 1.5. Impaired renal or hepatic function 1.6. Severe depression 1.7. Use of mono-amine oxidase inhibitors (MAOIs)as anti-depressants 1.8. Anorexia nervosa or bulimia nervosa 1.9. Porphyria 1.10. Milk protein allergy (the diet is milk based) 1.11. Severe lactose intolerance (the diet is milk based) 1.12. (Pregnant and lactating women, children below the age of 14) 2. Drug treated diabetes 3. Currently on a weight loss drug (Acomplia®, Reductil® or Xenical®) 4. Bariatric surgery 5. Recent angina pectoris or atrial fibrillation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of OSAS defined by AHI at 9 weeks (group-time interaction). Sleep registrations will be performed in duplicate with a seven channel home polygraphy equipment (WATCH_PAT 100, Itamar Medical Ldt, and Caesarea, Israel). Channels are for snoring, body position, peripheral arterial tone (PAT), pulse, oximetry, actigraphy and sleep staging. Respiratory Disturbance Index (RDI), AHI, sleep quality and quantity are derived from the PAT-signal, oximetry and actigraphy by a well defined and validated algorithm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the association between concentration of ketone bodies in the blood and euphoria during weight loss and to measure, anthropometry, metabolic markers, blood pressure, physical activity, quality of life and daytime sleepiness. Mean changes between groups (intervention and control group) between baseline and endpoint will be investigated for all variables. Clinical examinations will be conducted at screening, baseline, week 1, 3, 5, 7, 9 in the VLCD- and control group. In the control group measurements will also be performed at week 18, since these measurements are the "baseline data" of the one-year maintenance programme. 2. Improvement of OSAS defined by AHI and the other factors after 1 year maintenance programme (time interaction), for methods see primary outcome | — |
Countries
Sweden
Outcome results
None listed