Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

Washington University School of Medicine60 enrolled

Overview

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%),

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * AHI \> 65 o The guidelines for HGNS usage were originally approved for an AHI upper limit of 65. We will not enroll anyone in the study with an AHI greater than 65. * 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.

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: baseline(pre-treatment) and through study completion on average 8 weeks

Secondary Outcomes

Clinical Global Impressions-Improvement (CGI-I)

CGI-I scale is a tool used to assess the change in a patient's condition following treatment. It is adapted from the Clinical Global Impression of Improvement scale and specifically measures improvement in obstructive sleep apnea (OSA). Patients are asked to evaluate their current condition compared to their status prior to receiving therapy. The response options for the CGI-I include categories such as: * Very much improved, * Somewhat improved, * Minimally improved, * No change, * Minimally worse, * Somewhat worse, * Very much worse. This scale helps quantify the perceived effectiveness of the treatment from the patient's perspective during follow-up assessments. Patients responding at least "minimally improved improvement" will be defined as responders to treatment.

Time frame: through study completion on average 8 weeks

Epworth Sleepiness Scale (ESS) scores.

The Epworth Sleepiness Scale (ESS) is a self-reported questionnaire that measures daytime sleepiness. It consists of eight scenarios in which respondents rate their likelihood of dozing off or falling asleep on a scale from 0 to 3, with higher scores indicating greater levels of daytime sleepiness. The total score can range from 0 to 24, with scores above 10 typically suggesting excessive daytime sleepiness. ESS score is calculated as the difference in ESS score post-treatment minus ESS score pre-treatment.

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores.

The SNORE-25 is a measure of sleep-disordered breathing-related health burden over the past two weeks. It is derived from a 7-item reduction of the OSA Patient-Oriented Severity Index (OSAPOSI). The SNORE-25 uses a magnitude scale ranging from 0 to 5 for each of its twenty-five items, resulting in a final score range of 0 to 125. A clinically meaningful difference is a 50% change (decrease) from pretreatment. The change in SNORE-25 is calculated as the difference in SNORE-25 score post-treatment minus SNORE-25 pre-treatment.

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Measure of satisfaction with treatment

Measure of satisfaction with treatment will capture global indication of satisfaction with the treatment. Response options are: * Very dissatisfied, * Mildly satisfied, * Neither satisfied or dissatisfied, * Mildly satisfied, , and * Very satisfied

Time frame: and through study completion on average 8 weeks

The rate of subject re-selecting the treatment

Response options are: * I would definitely select this treatment again, * I would likely select this treatment again, * I would likely not select this treatment again, * I would never select this treatment again. The rate of subjects responding "…definitely select this treatment again" and"…likely select this treatment again" will be compared between the two study group.

Time frame: and through study completion on average 8 weeks

The rate of subjects recommending the treatment

Response options are: * I would definitely recommend this treatment, * I would likely recommend this treatment, * I would likely not recommend this treatment, * I would never recommend this treatment, The rate of subjects responding "…definitely recommend this treatment" and "…likely recommend this treatment" will be compared between the two study groups.

Time frame: and through study completion on average 8 weeks

Apnea-Hypopnea Index (AHI)

AHI is a measure of breathing interruptions during sleep. A higher AHI indicates more frequent breathing disruptions and more severe sleep apnea. A reduction in AHI indicates improved sleep apnea

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Oxygen Desaturation Index (ODI)

ODI is a measure of oxygen desaturations during sleep. A reduction in ODI indicates improved sleep apnea.

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Mean arterial saturation

Mean arterial saturation, which is a measure of peripheral artery oxygenation during sleep. An increase of mean arterial saturation indicates improved sleep apnea

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Time <90%

This is a measure of the time spent below an oxygen saturation of 90% during sleep. A reduction in time \< 90% indicates improved sleep apnea

Time frame: baseline (pre-treatment) and through study completion on average 8 weeks

Adverse events

Any undesirable experiences associated with the use of the intervention, which can include but are not limited to discomfort, pain, device-related issues, or other health problems.

Time frame: throughout the entire study period on average 10 weeks

Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts