- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03720353
Pharmacological Intervention for Symptomatic Snoring
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Women's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: 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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Aktiver Komparator: 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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Placebo-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Snoring intensity
Zeitfenster: 1 week
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mean tracheal snoring sound intensity (tracheal microphone), decibels
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1 week
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Snoring frequency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 week
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0-10 scale
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1 week
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Mean oxygen saturation
Zeitfenster: 1 week
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Percentage
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1 week
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Stage 1 Sleep
Zeitfenster: 1 week
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%Total sleep time
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1 week
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Arousal index
Zeitfenster: 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
Zeitfenster: 1 week
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0-10 scale
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1 week
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Epworth Sleepiness Scale
Zeitfenster: 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
Zeitfenster: 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?"
Zeitfenster: 1 week
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Yes/No
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1 week
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Maximum Tracheal Snoring Sound Intensity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 week
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0-10 scale
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1 week
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2018P002094
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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