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New treatment option for Sleep Apnea, Obstructive
Official title NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
ClinicalTrials.gov ID: NCT06677151
What this study is testing
- What it's testing
- This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capacity and willingness to sign consent
- Patient willingness to commit to and complete study over a 30-day time period
- Confirmed diagnosis of moderate to severe OSA (AHI \>= 15)
- OSA caused by upper airway obstruction
- CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an...
You likely can't join if
- Within 3 months of initiating CPAP use, and actively using CPAP
- Supraglottic airway collapse
- Distal airway stenosis
- Tracheobronchomalacia
- Currently pregnant
- Active COVID-19 infection
See the full eligibility criteria
- Capacity and willingness to sign consent
- Patient willingness to commit to and complete study over a 30-day time period
- Confirmed diagnosis of moderate to severe OSA (AHI \>= 15)
- OSA caused by upper airway obstruction
- CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
- Adequate manual dexterity to demonstrate ability to self-insert and remove device
- Within 3 months of initiating CPAP use, and actively using CPAP
- Supraglottic airway collapse
- Distal airway stenosis
- Tracheobronchomalacia
- Currently pregnant
- Active COVID-19 infection
- Need for anticoagulative therapy
- Severe nasal allergies
- Bleeding disorder
- More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time
- Restrictive thoracic disorders
- Silicone, lidocaine, neosynephrine allergy
- Recurrent epistaxis
- Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema)...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.