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.
Woolcock Institute for Medical Research
130 participants
Jul 6, 2012
Interventional
Conditions
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
Inclusion Criteria6
- Males & Females aged 18-70 years.
- General or central obesity. BMI:>=27 but less than 40kg/m2 or waist circumference >=80cm for women and >=94cm for men.
- Moderate-severe and symptomatic OSA (Apnea Hypopnea Index (AHI) >= 15/hr with concomitant daytime sleepiness ESS>=10 or clinical report of disturbing daytime sleepiness).
- Ambulatory and community-dwelling.
- Hold a current drivers license.
- Must have rejected CPAP and MAS within the past 2 years. Otherwise patients will be encouraged to recommence a standard mechanical treatment.
Exclusion Criteria15
- Pregnancy or lactation- the effects of this drug on pregnant women or their unborn or breastfed children is unknown and the obesity reduction program is NOT suitable for pregnant or lactating women. CAUTION: Fertile women should be warned that this class of medication is known to interfere with contraceptive pills and they should employ additional contraceptive strategies.
- Severe hypertension (SBP>=180 and/or DBP>=110).
- Patients with moderate-severe skin allergies and/or eczema should not be enrolled due to side effects of this drug class being reported in these patients.
- Shift workers who rotate to night shift.
- Unstable Angina / Heart Failure (NYHA Class III and IV)/ Stroke.
- Current use of device based treatment (CPAP, MAS or positional treatment) OR upper airway surgery with 6 months.
- Cognitive impairment / Psychiatric disorder / Physically unable to participate.
- Severe OSA (minimum oxygen saturation < 65% or RDI > 100) or excessively sleepy patients at increased risk for driving-related accidents requiring immediate treatment.
- More than 20% of AHI with central apneas.
- Previous use of Modafinil or Armodafinil
- Alcohol or Caffeine dependence as patients undergo multiple 24 hours periods in our sleep laboratory without access to these.
- Cytochrome P450 affecting drugs
- Patients with severe tonsillar enlargement or nasal obstruction will be referred to an ENT surgeon for surgical intervention before an additional attempt at CPAP or MAS use.
- Severe Haemophobics as we must take blood as a safety check in this study.
- Participation in a drug trial or lifestyle modification program within the preceding three months.
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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.
Locations(1)
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ACTRN12611000847910