Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

Study Overview
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Brief Summary
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The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work is to verify this hypothesis. The literature data demonstrate that a BCAA complementation improves the physical performances, protects lean mass and increases VO2 max during training. We demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.

Official Title
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Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?

Conditions
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Sleep Apnea

Intervention / Treatment
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* Drug: Branched-chain aminoacids
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult with healthy mind, who has attained his majority, and affiliated to Social Security. Patient suffering from SAS confirmed by polysomnography (PSG). Written informed consent form signed. Exclusion Criteria: Patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study. Patients suffering for severe SAS : those who have a number of IAH higher than 30 in a validated sleep hour, will be excluded for security reasons. Pregnant women, nursing mothers or women susceptible to procreate without efficient contraception. Patient presenting hypersensitivity to understudying products and their excipients.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Branched-chain aminoacids<br>Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules. | Drug: Branched-chain aminoacids<br>* Branched-chain aminoacids will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day. Every capsule containing 375 milligrams of branched-chain aminoacids. The treatment will last 3 weeks.<br>|
| Placebo Comparator: placebo<br>The placebo will be orally administered in the form of capsules | Drug: Placebo<br>* Placebo will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day. The treatment will last 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The principal criterion of BCAA efficacy is based on the depth of arterial desaturation during sleep, assessed by the level of SaO2 during the validated sleep time measured during the polysomnography performed at the end of the study. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations. |  | 2 years |