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

August 20, 2018 updated by: University Hospital, Limoges

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I08024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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