Clinical Trials Logo
  1. Home
  2. Sleep Disordered Breathing
  3. NCT00773591

Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders — Snoring  

Sleep-Disordered Breathing Clinical Trial

Official title:
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)

Clinical Trial Summary

This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.

Clinical Trial Description

Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group.

Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.

Primary variable:

Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00773591
Study type Interventional
Source Merz Pharmaceuticals GmbH
Contact
Status Withdrawn
Phase Phase 2
Start date March 2010
Completion date October 2010
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Recruiting NCT01785199 - Effects of Head Elevation by a Bed on Sleep-disordered Breathing Phase 1
Recruiting NCT06043830 - Managing Opioid Related Sleep Apnea With Acetazolamide Phase 2
Recruiting NCT04351698 - SMILES: Study of Montelukast in Sickle Cell Disease Phase 2/Phase 3
Active, not recruiting NCT05643352 - Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring N/A
Recruiting NCT03142022 - Sleep-disordered Breathing After Solid Organ Transplantation
Recruiting NCT05336890 - Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Recruiting NCT05466864 - Screening of OSA in Hospitalized Stroke Patients Using BSP N/A
Recruiting NCT05661747 - Dental Appliance to Treat SDB in Children Phase 4
Completed NCT02855515 - Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea N/A
Recruiting NCT05575401 - Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy N/A
Completed NCT02923505 - Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
Recruiting NCT06154577 - Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
Recruiting NCT04331821 - READ-ASV Registry - Phase II
Completed NCT02830074 - Treatment of Sleep-disordered Breathing in Patients With SCI N/A
Completed NCT02760680 - Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02245659 - Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial N/A