CompletedNot Applicable

Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

United States2 participantsStarted 2021-09-01

Plain-language summary

Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.

Who can participate

Age range

3 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children with HUAO: This includes those who newly diagnosed with OSA. These children will undergo overnight polysomnography to determine the presence of OSA (AHI\>10 or AHI\>5 with nocturnal hypoxemia defined as SpO2 nadir \<=75%). * Obstructive sleep apnea on polysomnogram with AHI\>=10 * Presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors) * Post adeonotonsillectomy or those with contraindications to tonsillectomy. * obstructive sleep apnea on polysomnogram with AHI\>=10 * Tonsil size 2+ or smaller * Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate. Exclusion Criteria: * AHI ≤10 on polysomnogram without hypoxemia or AHI\<5 with hypoxemia - any reason why ssNPA may not be suitable * Any medical reason why ssNPA therapy may not be suitable * Active COVID 19 infections * ETCO2 or TCO2 values \>60 mmHg for \>10% of sleep time on PSG * Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ability to Tolerate Measured by Percent of Participants With Protocol Goal

Timeframe: 8 weeks

Comfort as Measured by Percent of Participants With Protocol Objective Score

Timeframe: 8 weeks

Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal

Timeframe: 8 weeks

Trial details

NCT IDNCT04846400

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

Results submitted2023-06-27

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials

Plain-language summary

Who can participate

Age range

3 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ability to Tolerate Measured by Percent of Participants With Protocol Goal

Timeframe: 8 weeks

Comfort as Measured by Percent of Participants With Protocol Objective Score

Timeframe: 8 weeks

Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal

Timeframe: 8 weeks