Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

Sponsor

University Hospital, Limoges (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01115686

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Drug: Branched-chain aminoacids Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jun 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

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. [2 years]

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. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT01115686

Other Study ID Numbers:

I08024

First Posted:

May 4, 2010

Last Update Posted:

Aug 22, 2018

Last Verified:

Apr 1, 2010

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Study Results

No Results Posted as of Aug 22, 2018