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Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

Information source: University Hospital, Limoges
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Apnea

Intervention: Branched-chain aminoacids (Drug); Placebo (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: University Hospital, Limoges


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult with healthy mind, who has attained his majority, and affiliated to Social


- 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


- Patient presenting hypersensitivity to understudying products and their excipients.

Locations and Contacts

Additional Information

Starting date: June 2010
Last updated: December 4, 2012

Page last updated: August 23, 2015

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