Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS) (ARSAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115686
Recruitment Status : Withdrawn
First Posted : May 4, 2010
Last Update Posted : December 5, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Branched-chain aminoacids Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Branched-chain aminoacids
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

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.

Placebo Comparator: placebo
The placebo will be orally administered in the form of capsules
Drug: Placebo

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.

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Marie SENGELEN / Director of Research and Innovation, University Hospital, Limoges Identifier: NCT01115686     History of Changes
Other Study ID Numbers: I08024
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: April 2010

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases