Sleep Apnea
Conditions
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| 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. | 2 years |
Secondary
| 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. | 2 years |
Outcome results
None listed