Back to resultsBranched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS) (ARSAS)
Primary Purpose
Sleep Apnea
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Branched-chain aminoacids
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Branched-chain aminoacids
placebo
Arm Description
Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
The placebo will be orally administered in the form of capsules
Outcomes
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.
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.
Full Information
NCT ID
NCT01115686
First Posted
April 30, 2010
Last Updated
August 20, 2018
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT01115686
Brief Title
Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)
Acronym
ARSAS
Official Title
Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Withdrawn
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Branched-chain aminoacids
Arm Type
Active Comparator
Arm Description
Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will be orally administered in the form of capsules
Intervention Type
Drug
Intervention Name(s)
Branched-chain aminoacids
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)
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