CompletedPhase 2Phase 3ACTRN12611000847910

Diet Exercise and ARmodafinil for treatment resistant sleep apnea (DEAR)

Factorial trial for treating sleepy overweight or obese sleep apnea patients who cannot use standard treatments comparing hypocaloric diet with high protein/ low glycemic index diet for fat mass reduction and simultaneously comparing armodafinil with placebo for improving simulated driving ability and neuro-behavioural functioning.

Sponsor

Woolcock Institute for Medical Research

Enrollment

130 participants

Start Date

Jul 6, 2012

Study Type

Interventional

Conditions

Obesity Sleep Apnea

Summary

This is a clinical trial for patients with sleep apnea who cannot use the standard treatments: continuous positive airway pressure machines or mandibular advancement splints. In this study we are testing two types of treatments at the same time, one a drug-based treatment and one a diet and exercise treatment, in combination we hope these will reduce sleep apnea and control its daytime symptoms. Patients will be randomly assigned to one of two types of diet for 12 months, a standard low calorie diet versus a diet which is high in protein and low in glycemic index (Low GI). Both of these groups will participate in the same lifestyle program promoting activity, exercise and healthier choices. The drug based treatment is testing a drug called Armodafinil for 9 months. Armodafinil is a drug that promotes wakefulness but does not improve your sleep apnea directly. So we think that it may improve other secondary outcomes including ability to concentrate, particularly whilst driving. We will be comparing Armodafinil to an inert placebo which does not have any active ingredient.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

The DEAR study tests a combination of diet, exercise, and the wakefulness drug armodafinil for treating sleep apnea in overweight or obese adults aged 18-70 who have rejected standard treatments like CPAP or oral appliances. Participants must have moderate-to-severe obstructive sleep apnea with daytime sleepiness and hold a current driver's licence.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This is a factorial trial which means we are testing two types of intervention in the same patients starting at the same time. This means that all patients will be in both the Drug trial and the Lifestyle trial at the same time until the final 3 months of the trial when they will only be on the diet. This is also a parallel study design which means once a patient has been randomly allocated to their intervention groups they will not crossover to the other intervention program. At baseline patients will see an exercise physiologist and dietitian for approximately 1.5 hours in an individual consultation. They will then participate in individual sessions conducted by the exercise physiologist/dietitian running for 1.5-2 hours at 2 weeks, 1 month and 4.5 month timepoints. Patients will also recieve a phonecall from exercise physiologist/dietitian at 1.5 months to review their progress. Further approx 1 hour individual consultations at 6, 9 and 12 months to review their progress with the dietitian and exercise physiologist. The Drug Trial is a Superiority Trial (i.e. is the drug better than the placebo?): 3x50mg tablets (ie 150mg) of Armodafinil or placebo once in the morning for 9 months. The Lifestyle Trial is an Equivalence Trial (i.e. are these two diets similarly effective interventions?): Participants will also be randomly allocated for 12 months to either a low GI/high protein diet or a standard low calorie diet as a part of an individualized lifestyle modification program also providing exercise and lifestyle recommendations.