Habitual Snoring
Conditions
Brief summary
The purpose of this study is to identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.
Interventions
Subject to receive one injection of either 2.5U, 5U or 7.4U of IncobotulinumtoxinA. For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per 50U vial, respectively, resulting in a concentration of 6.25 U/ml, 12.5 U/ml and 18.5 U/ml. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.
DRUGPlacebo Comparator
For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per vial, respectively. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female or male subjects aged 18-70 * Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring * Subjects with a peak Snoring Index \[SI\] ≥ 15/ hour of sleep \[h\] at baseline visit * Subjects with a bed partner for at least three months prior to study start. * Subjects who understand the nature of the study and provide written Informed Consent at screening visit. * Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study
Exclusion criteria
* Obese subjects (Body Mass Index ≥ 30) * Subjects with severe obstructive sleep apnea syndrome * Subjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit * Subjects who have undergone any Botulinum neurotoxin treatment in the history * Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome) * Acute infections of the pharynx
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from baseline in Snoring Index at week 4 | Baseline to week 4 | Snoring Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in Snoring Index at week 4 | Baseline to week 4 | — |
| Bed partner satisfaction | Week 4 | Bed partner satisfaction to assess the global effect of the treatment. |
| Change from baseline in loudness at week 4. | Baseline to week 4 | Sone is employed as the unit of the perceived loudness. |
Countries
Germany
Outcome results
None listed