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Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01115686
First received: April 30, 2010
Last updated: December 4, 2012
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Sleep Apnea
 Drug: Branched-chain aminoacids
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marie SENGELEN / Director of Research and Innovation, University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01115686     History of Changes
Other Study ID Numbers: I08024
Study First Received: April 30, 2010
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 19, 2013