Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

Sleep Apnea Clinical Trial

— ARSAS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01115686
• Other study ID #: I08024
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: April 2010
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.		2 years