Effects of weight loss on obstructive sleep apnoea syndrome (OSAS): a randomised controlled trial

Completed

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

• Registration Number: ISRCTN70090382
• Lead Sponsor: Cambridge Manufacturing Company Limited (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified