Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

Phase 3

Withdrawn

• Conditions: Sleep Apnea
• Interventions: Drug: Branched-chain aminoacids; Drug: Placebo

• Registration Number: NCT01115686
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Study Start: 2010-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Branched-chain aminoacids	Branched-chain aminoacids	Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
placebo	Placebo	The placebo will be orally administered in the form of capsules

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.	2 years