Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

NCT01115686 | Withdrawn Phase 3 DMC

• 1 other identifier: I08024
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.

  2 years

Study Arms (2)

Branched-chain aminoacids

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

The placebo will be orally administered in the form of capsules

Drug: Placebo

Interventions

Branched-chain aminoacids DRUG

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.

Branched-chain aminoacids

Placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 22, 2018

Record last verified: 2010-04