Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives (OSANOVA): Comparison of Mandibular Advancement Device and Hypoglossal Nerve Stimulation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients).
The primary aim of the study is to compare the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Primary Outcome measures include changes in Pittsburgh Sleep Quality Index (PSQI) scores.
Secondary aims will help us describe the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Secondary outcome measures include:
- adverse events,
- Epworth Sleepiness Scale (ESS),
- Symptoms of Nocturnal Obstruction and Related Events (SNORE-25),
- patient-reported satisfaction,
- CGI-Improvement,
- the rate of subjects re-selecting the treatment, and
- the rate of subjects recommending the treatment. and
- changes in sleep study metrics (i.e., AHI, ODI, mean arterial saturation, and Time<90%),
详细描述
The study will enroll and follow a cohort of PAP-failing patients receiving MAD therapy and a second cohort receiving HGNS therapy. Baseline and post-intervention patient-reported outcome measures (PROMs) and standard sleep study parameters to evaluate and compare treatment efficacy will be captured.
Both MAD and HGNS are accepted treatments for moderate OSA patients following PAP intolerance, refusal, or failure. Current decision-making is based heavily on patient preference rather than well-defined evidence-based recommendations. Choosing the right therapy is a crucial aspect of treatment for OSA, a chronic and lifelong condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must consent to being a part of the study
- •Must be willing and able to physically present to the our office site on the Hospital campus whenever necessary over the course of the study
- •Able to read, write, speak, and understand English
- •Willing to complete study surveys over the course of the study.
- •Must have a diagnosis for moderate to severe OSA (AHI ≥15) with indications for PAP therapy OSA is stratified into mild (5 ≤ AHI ≤ 15), moderate (15 < AHI ≤ 30), and severe (AHI>30)
- •Must have declined PAP therapy (unwillingness to use), failed PAP therapy (AHI > 15 on PAP), or are inadherent to PAP therapy (not using PAP ≥4 hours/night for ≥5 nights per week, also defined as intolerance to PAP)
- •Age ≥ 18 years
- •BMI ≤ 40 kg/m²
- •Central/Mixed apneas contribute < 25% of AHI (Predominantly Obstructive Sleep Apnea)
- •Willing to complete pre-intervention and post-intervention sleep studies
- •Planning to obtain MAD or HGNS as part of clinical care
排除标准
- •AHI > 65
- •o The guidelines for HGNS usage were originally approved for an AHI upper limit of
- •We will not enroll anyone in the study with an AHI greater than
- •Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition (edentulism) to support appliance retention, and inadequate range of motion of the jaw. Similarly, patients undergoing dental realignment (e.g., braces or retaining device) are not suitable candidates.
- •Chronic nasal obstruction
- •Individuals without manual dexterity to place and remove the device such as those afflicted with severe arthritis, or neuromuscular disease that affects dexterity.
- •Prior intolerance to MAD
- •Rapid therapy required: patients in whom rapid initiation of treatment is desirable (e.g., patients with severe symptomatic OSA, sleepiness while driving) and they declined PAP without PAP failure. PAP therapy can be initiated quickly while MAD initiation requires incremental titration of the device over weeks to months to attain optimal efficacy.
- •Severe or prolonged Oxygen desaturation: patients with severe oxyhemoglobin desaturation during sleep (e.g., nadir peripheral oxygen saturation [SpO2] <70 percent), caution is warranted as oral appliance therapy may not provide optimal improvement in oxygenation.
- •Alcohol or illicit substance use at least daily
- •Unstable psychiatric condition
- •Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.
研究组 & 干预措施
Hypoglossal Nerve Stimulation (HGNS) therapy
This arm consists of patients who will receive hypoglossal nerve stimulation therapy, another accepted treatment option for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.
干预措施: HGNS (Device)
Mandibular Advancement Device (MAD) therapy
This arm includes patients who will receive treatment with a mandibular advancement device, which is an accepted therapy for moderate obstructive sleep apnea (OSA) patients following intolerance, refusal, or failure of positive airway pressure (PAP) therapy.
干预措施: MAD (Device)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: baseline(pre-treatment) and through study completion on average 8 weeks
Pittsburgh Sleep Quality Index (PSQI) asks patients to reflect on their sleep experiences over the last month prior to assessment. The global PSQI score is calculated by summing all seven components scores (i.e., subjective sleep quality,sleep latency, sleep duration, habitual sleep efficiency,sleep disturbances, use of sleeping medication and daytime dysfunction). Each component is scored between 0 and 3, resulting in a total PSQI score ranging from 0 to 21. A higher score indicates poorer sleep quality, with a global sum greater than 5 signifying poor sleep quality. The change in PSQI is calculated as the difference in PSQI score post-treatment minus PSQI score pre-treatment.
次要结局
- Clinical Global Impressions-Improvement (CGI-I)(through study completion on average 8 weeks)
- Epworth Sleepiness Scale (ESS) scores.(baseline (pre-treatment) and through study completion on average 8 weeks)
- Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores.(baseline (pre-treatment) and through study completion on average 8 weeks)
- Measure of satisfaction with treatment(and through study completion on average 8 weeks)
- Clinical Global Impressions-Improvement (CGI-I)(through study completion on average 8 weeks)
- Epworth Sleepiness Scale (ESS) scores.(baseline (pre-treatment) and through study completion on average 8 weeks)
- Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores.(baseline (pre-treatment) and through study completion on average 8 weeks)
- Measure of satisfaction with treatment(and through study completion on average 8 weeks)
- The rate of subject re-selecting the treatment(and through study completion on average 8 weeks)
- The rate of subjects recommending the treatment(and through study completion on average 8 weeks)
- Apnea-Hypopnea Index (AHI)(baseline (pre-treatment) and through study completion on average 8 weeks)
- Oxygen Desaturation Index (ODI)(baseline (pre-treatment) and through study completion on average 8 weeks)
- Mean arterial saturation(baseline (pre-treatment) and through study completion on average 8 weeks)
- Time <90%(baseline (pre-treatment) and through study completion on average 8 weeks)
- Adverse events(throughout the entire study period on average 10 weeks)
研究者
Jay F. Piccirillo, MD
Professor of Otolaryngology
Washington University School of Medicine