Effect of Fenofibrate on Sleep Apnea Syndrome

Study Overview
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Brief Summary
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Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

Official Title
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A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

Conditions
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Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity

Intervention / Treatment
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* Drug: Placebo
* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m². Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion. Exclusion Criteria: indication for immediate CPAP other known endocrine disease, except treated and adequately controlled hypothyroidism renal failure or plasma creatinine level >130 µmol/L current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL) symptomatic gallbladder disease known muscular disease or creatine phosphokinase (CK) > 3 times UNL.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Fenofibrate-matching placebo tablet | Drug: Placebo<br>* Fenofibrate-matching placebo tablet<br>|
| Experimental: 2<br>145 mg NanoCrystal fenofibrate tablet | Drug: Fenofibrate<br>* 145 mg NanoCrystal tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive Apneas | Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts). | at one month of treatment | 
| Desaturations | Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment. | at one month of treatment | 
| Sleep Time With Oxygen Saturation Below 90% | Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients. | at one month of treatment | 
| Apneas | Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment | at one month of treatment | 
| Hypopneas | Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment. | at one month of treatment | 
| Index Apnea/Hypopnea | Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment. | at one month of treatment | 
| Mixed Apneas | Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment. | at one month of treatment | 
| Central Apneas | Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment. | at one month of treatment | 
| Index of Apneas | Average number of apneas per hour of sleep during one night after one month of treatment. | at one month of treatment | 
| Index of Hypopneas | Average number of hypopneas per hour of sleep during one night after one month of treatment. | at one month of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients