Sleep Apnea Syndrome, ObstructivePhase 2ARAP1NCT07399782
Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea
A Phase 2 study testing BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE in people with Sleep Apnea Syndrome, Obstructive and Sleep Apnea Syndrome (OSAS), run by Hospital Felicio Rocho.
Trial summary
Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by recurrent collapse of the upper airway during sleep, in which the palatopharyngeal muscle plays a key role in pathophysiology. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome
- What is being tested?
- BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of moderate to severe OSA, confirmed by home or laboratory polysomnography.
- Age between 18 and 50 years.
- BMI in the range of 18.5-30.
- Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women).
- Absence of signs of upper obstruction
Who cannot join
- Skeletal or craniofacial disorders:
- Tonsillar hypertrophy 3-4
- Obesity (BMI > 30 kg/m²)
- Elderly (age > 50 years)
- Neuromuscular diseases (e.g., dystrophies, myasthenia gravis)
- Chronic use of medications that alter muscle tone.
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- Excessive alcohol consumption (> 14 drinks/week)
- Chronic obstructive pulmonary disease (COPD)
- Congestive heart failure (NYHA III-IV) or decompensated heart disease.
- Concomitant sleep disorders: narcolepsy, restless legs syndrome, sleep behavior disorder (REM).
- Predominant central or mixed sleep apnea on polysomnography (≥ 50% central events).
- Previous airway surgery (uvulopalatopharyngoplasty, recent tonsillectomy).
- Pregnancy or postpartum (< 6 months).
- Neurological conditions: Previous stroke, Parkinson's disease, dementia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA
Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by recurrent collapse of the upper airway during sleep, in which the palatopharyngeal muscle plays a key role in pathophysiology. Although continuous positive airway pressure (CPAP) remains the standard treatment, adherence is often suboptimal. Botulinum toxin type A (BoNT-A), a peripheral neuromodulator, has been proposed as a potential therapeutic alternative by inducing chemodenervation and muscle volume reduction, thereby potentially increasing upper airway patency. This study aims to evaluate the efficacy and safety of BoNT-A injection into the palatopharyngeal muscle in patients with moderate to severe OSA. This is a prospective, single-arm, interventional clinical trial with pre- and post-intervention assessment. We hypothesize that the intervention will result in a significant reduction in the Apnea-Hypopnea Index (AHI), along with improvements in secondary outcomes such as excessive daytime sleepiness and oxygenation parameters.
- Conditions
- Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive
- Being tested
- BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLEDrug
Botulinum toxin will be injected into the palatopharyngeal muscle in patients undergoing Medication-Induced Sleep Endoscopy. The injection will be performed while visualizing the posterior pharyngeal constriction.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin | Experimental | BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE Receives: Drug: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.
Measured: 12 months
Secondary outcomes (3)
Minimum oxygen saturation (SpO₂)
Verify the impact of the intervention on minimum oxygen saturation (SpO₂)
Measured: 12 months
Epworth Sleepiness Scale
Analyze the change in excessive daytime sleepiness, using the Epworth Sleepiness Scale, before and after the application of botulinum toxin.
Measured: 12 months
Oxygen desaturation index (ODI).
Verify the impact of the intervention on oxygen desaturation index (ODI).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start5 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea Syndrome, ObstructiveStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Felicio Rocho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Rodrigues de Almeida Paiva, Hospital Felicio Rocho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399782
- Sponsor's protocol ID
- 90369725.9.0000.5125
- Other IDs
- 121415
- Acronym
- ARAP1
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, Weight, Height, Sex, Test Results, Questionnaire Results, Contact Telephone Number, Intervention Location, Information on Procedures, Procedure Videos
Publications
Swislocki ALM, Eisenberg ML. Peyronie Disease as a Marker of Inflammation-Is There Hope on the Horizon? Am J Med. 2021 Oct;134(10):1218-1223. doi: 10.1016/j.amjmed.2021.06.015. Epub 2021 Jul 14.
PubMed 34273285Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008.
PubMed 20086074
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA
- ClinicalTrials.gov ID
- NCT07399782
- Acronym / sponsor ID
- ARAP1 / 90369725.9.0000.5125
- Conditions
- Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Felicio RochoUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- 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.
Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by recurrent collapse of the upper airway during sleep, in which the palatopharyngeal muscle plays a key role in pathophysiology. Although continuous positive airway pressure (CPAP) remains the standard treatment, adherence is often suboptimal. Botulinum toxin type A (BoNT-A), a peripheral neuromodulator, has been proposed as a potential therapeutic alternative by inducing chemodenervation and muscle volume reduction, thereby potentially increasing upper airway patency. This study aims to evaluate the efficacy and safety of BoNT-A injection into the palatopharyngeal muscle in patients with moderate to severe OSA. This is a prospective, single-arm, interventional clinical trial with pre- and post-intervention assessment. We hypothesize that the intervention will result in a significant reduction in the Apnea-Hypopnea Index (AHI), along with improvements in secondary outcomes such as excessive daytime sleepiness and oxygenation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin | Experimental | Drug: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLEBOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of moderate to severe OSA, confirmed by home or laboratory polysomnography.
- Age between 18 and 50 years.
- BMI in the range of 18.5-30.
- Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women).
- Absence of signs of upper obstruction
Key exclusion criteria (14 listed)
- Skeletal or craniofacial disorders:
- Tonsillar hypertrophy 3-4
- Obesity (BMI > 30 kg/m²)
- Elderly (age > 50 years)
- Neuromuscular diseases (e.g., dystrophies, myasthenia gravis)
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 |
|---|---|---|
| BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLEBotulinum toxin will be injected into the palatopharyngeal muscle in patients undergoing Medication-Induced Sleep Endoscopy. The injection will be performed while visualizing the posterior pharyngeal constriction. | Drug | Botulinum toxin |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 12 months
Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.
3 secondary outcomes
Minimum oxygen saturation (SpO₂)
Time frame: 12 months
Epworth Sleepiness Scale
Time frame: 12 months
Oxygen desaturation index (ODI).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 34273285Swislocki ALM, Eisenberg ML. Peyronie Disease as a Marker of Inflammation-Is There Hope on the Horizon? Am J Med. 2021 Oct;134(10):1218-1223. doi: 10.1016/j.amjmed.2021.06.015. Epub 2021 Jul 14.
- Results publication: PubMed 20086074Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008.
- Individual participant dataSharing planned: Yes. Age, Weight, Height, Sex, Test Results, Questionnaire Results, Contact Telephone Number, Intervention Location, Information on Procedures, Procedure Videos
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE in people with Sleep Apnea Syndrome, Obstructive and Sleep Apnea Syndrome (OSAS), run by Hospital Felicio Rocho.
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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 10 Feb 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan Rodrigues Paiva, MSc (+55 31 9 96869586, alanrodriguesmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: 12 months). 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 NCT07399782, which also lists 2 linked publications.
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 10 Feb 2026.