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Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

U

University of Limoges (UL)

Status and phase

Withdrawn
Phase 3

Conditions

Sleep Apnea

Treatments

Drug: Branched-chain aminoacids
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Branched-chain aminoacids
Active Comparator group
Description:
Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
Treatment:
Drug: Branched-chain aminoacids
placebo
Placebo Comparator group
Description:
The placebo will be orally administered in the form of capsules
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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