Trials / Not Yet Recruiting
Not Yet RecruitingNCT07399782
Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea
EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Hospital Felicio Rocho · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE | 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. |
Timeline
- Start date
- 2026-04-05
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2026-02-10
- Last updated
- 2026-02-10
Source: ClinicalTrials.gov record NCT07399782. Inclusion in this directory is not an endorsement.