- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03720353
Pharmacological Intervention for Symptomatic Snoring
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Snoring intensity
기간: 1 week
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mean tracheal snoring sound intensity (tracheal microphone), decibels
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1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Snoring frequency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 week
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0-10 scale
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1 week
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Mean oxygen saturation
기간: 1 week
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Percentage
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1 week
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Stage 1 Sleep
기간: 1 week
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%Total sleep time
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1 week
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Arousal index
기간: 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
기간: 1 week
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0-10 scale
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1 week
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Epworth Sleepiness Scale
기간: 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
기간: 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?"
기간: 1 week
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Yes/No
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1 week
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maximum Tracheal Snoring Sound Intensity
기간: 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
기간: 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
기간: 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
기간: 1 week
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0-10 scale
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1 week
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2018P002094
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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