Sleep ApneaPhase 3ARSASNCT01115686

Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

A Phase 3 study testing Branched-chain aminoacids in people with Sleep Apnea, run by University Hospital, Limoges.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Apnea
What is being tested?: Branched-chain aminoacids
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2010to Jun 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

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
Being tested: Branched-chain aminoacids, Placebo
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Branched-chain aminoacidsDrug
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.
PlaceboDrug
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.

Study groups in NCT01115686
Study group	Role	What they receive
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. Receives: Drug: Branched-chain aminoacids
placebo	Placebo comparator	The placebo will be orally administered in the form of capsules Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jun 2012

First posted4 May 2010 (estimated)
Study startJun 2010
Primary completionJun 2012 (estimated)
Study completionJun 2012 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by University Hospital, LimogesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01115686
Sponsor's protocol ID: I08024
Acronym: ARSAS
Status last verified: Apr 2010
First submitted: 30 Apr 2010
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?
ClinicalTrials.gov ID: NCT01115686
Acronym / sponsor ID: ARSAS / I08024
Conditions: Sleep Apnea
Phase: Phase 3
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: University Hospital, LimogesUniversity, hospital or other
Study start: Jun 2010
Primary completion: Jun 2012 (estimated)
Study completion: Jun 2012 (estimated)
First posted: 4 May 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Branched-chain aminoacids	Active comparator	Drug: Branched-chain aminoacidsBranched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
placebo	Placebo comparator	Drug: PlaceboThe placebo will be orally administered in the form of capsules

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Branched-chain aminoacidsBranched-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.	Drug	Branched-chain aminoacids
PlaceboPlacebo 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.	Drug	placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Branched-chain aminoacids in people with Sleep Apnea, run by University Hospital, Limoges.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01115686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.