- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03720353
Pharmacological Intervention for Symptomatic Snoring
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Two active interventions are being studied and compared against placebo. Participants will therefore be randomized to one of six possible sequences. Washout periods will be 1 week.
Effects of interventions on outcomes will be assessed using mixed effect model analyses: we will quantify the effect of active treatment 1 (referenced to placebo), the effect of active treatment 2 (referenced to placebo), adjusting for effects of time (period number), carryover effects, and baseline values (fixed effects). Participants are considered random effects.
Primary outcome is based on significance of active intervention 1 versus placebo.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria for Enrollment
- Age 18-79 yrs
- Self-reported habitual snoring ("most of the time" or "all of the time" on Snoring Self-Evaluation Scale)
Sleep-related symptoms defined by any of the following*:
- Visual-Analog Scale for Sleep Quality ≤7/10 ("reduced sleep quality")
- Epworth Sleepiness Scale ≥10 ("excessive daytime sleepiness")
- Functional Outcomes of Sleep Questionnaire <18 ("reduced sleep-related quality of life").
Presence of a bed-partner who is able to provide feedback to the participant on snoring (Snoring Bed-Partner Evaluation Scale)
- The intention of these criteria is to enable participants with a broad range of possible snoring symptoms to be included. We note that the Visual-Analog Scale for Sleep Quality is, on average, approximately 7/10 in patients with sleep apnea; thus, we consider a value at or below 7 to indicate "reduced sleep quality".
Exclusion Criteria for Enrollment
- Known obstructive sleep apnea (OSA, except "mild")
- Current treatment for OSA or snoring (continuous positive airway pressure, oral appliances, supplemental oxygen)
- Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
- Use of similar medications to the study drugs.
- Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
Respiratory disorders other than sleep disordered breathing:
o chronic hypoventilation/hypoxemia (awake oxygen saturation < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
- Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
Contraindications to the study drugs, including:
- clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2)
- clinically-significant liver disorders
clinically-significant cardiovascular conditions
- severe hypertension (systolic blood pressure above 180 mmHg or diastolic below 110 mmHg measured at baseline)
- cardiomyopathy (left ventricular ejection fraction, LVEF<50%) or heart failure
- advanced atherosclerosis
- history of cerebrovascular events
- history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
- other serious cardiac conditions
- myasthenia gravis
- pregnancy/breast-feeding
We will not make new measurements of eGFR, LVEF or document their presence/absence for each participant.
Criteria for Randomization
After the baseline visit, the following criteria need to be met to continue participation:
- Participants with AHI≥15 events/hr (moderate-to-severe OSA, hypopneas based on a 30% reduction in flow, accompanied by either a 3% oxygen desaturation or scored EEG-arousal) on the baseline study night, will not continue further participation after the baseline visit.
- Participants must exhibit evidence of snoring during the baseline sleep study for further participation (mean tracheal sound intensity, Leq, exceeding 80 dB); the precise cutoff will be pilot tested in ongoing protocols (where snoring is routinely measured).
Thus, strictly, the study population will include patients with symptomatic habitual snoring, with or without mild OSA (i.e. AHI<5 and 5≤AHI<15). We note that studies in patients with moderate-to-severe OSA have already been performed (AHI>15), and further studies in this population are in progress. The inclusion of "mild OSA" will prevent a gap in the inclusion criteria for the investigation of the current intervention.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Active H
Participants will take SAS2094AL and SAS2094BH for 3 days, then SAS2094AH and SAS2094BH for 7 days.
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SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
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Comparateur actif: Active L
Participants will take SAS2094AL and SAS2094BL for 10 days
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SAS2094AL and SAS2094BL for 10 days
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Comparateur placebo: Placebo
Participants will take placebo for 10 days.
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Placebo for 10 days.
Capsules will mimic active treatments.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Snoring intensity
Délai: 1 week
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mean tracheal snoring sound intensity (tracheal microphone), decibels
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1 week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Snoring frequency
Délai: 1 week
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snoring frequency (tracheal microphone), snores per hour of total sleep time
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1 week
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Snoring Self-Evaluation Scale
Délai: 1 week
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frequency, loudness, disruption, bothersome, 5-point scales
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1 week
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Snoring Bed-Partner Evaluation Scale
Délai: 1 week
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frequency, loudness, disruption, bothersome, 5-point scales
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1 week
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Flow-limitation frequency
Délai: 1 week
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breaths per hour (nasal pressure airflow shape)
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1 week
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Flow-limitation severity
Délai: 1 week
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flow:drive ratio (nasal pressure airflow shape), %
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1 week
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Visual-Analog Scale for Sleep Quality
Délai: 1 week
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0-10 scale
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1 week
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Mean oxygen saturation
Délai: 1 week
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Percentage
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1 week
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Stage 1 Sleep
Délai: 1 week
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%Total sleep time
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1 week
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Arousal index
Délai: 1 week
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events per hour of total sleep time
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1 week
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Visual-Analog Scale for Treatment Satisfaction
Délai: 1 week
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0-10 scale
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1 week
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Epworth Sleepiness Scale
Délai: 1 week
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units on a scale
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1 week
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Functional Outcomes of Sleep Questionnaire
Délai: 1 week
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30 items, units on a scale
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1 week
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"Would you keep using this medication?"
Délai: 1 week
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Yes/No
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1 week
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maximum Tracheal Snoring Sound Intensity
Délai: 1 week
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Maximum Tracheal Snoring Sound Intensity, "L1", based on 99th percentile of snoring sound intensity expressed in decibels (dB)
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1 week
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Visual-Analog Scales for Excessive Fatigue
Délai: 1 week
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0-10 scale
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1 week
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Visual-Analog Scales for Wake-up Unrefreshed
Délai: 1 week
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0-10 scale
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1 week
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Visual-Analog Scales for Low Energy
Délai: 1 week
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0-10 scale
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1 week
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2018P002094
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur SAS2094AH and SAS2094BH
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