Hypotonia, MuscleNCT06614582
Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
A study testing Self-Supporting Nasopharyngeal Airway (ssNPA) in people with Hypotonia, Muscle and Obstructive Sleep Apnea, run by University of Michigan at 1 site in United States.
Trial summary
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 3 to 23 years
- Conditions the study is for
- Hypotonia, Muscle, Obstructive Sleep Apnea, Nasal Airway Obstruction
- What is being tested?
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
- Willingness to continue device usage.
- Confirmed diagnosis of OSA (apnea/hypopnea index; AHI \> 10 or AHI \>5 with lowest oxygen level ≤75%)
- At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
- Previous adenotonsillectomy (unless tonsillectomy not possible)
- Tonsil size 2+ or smaller
Who cannot join
- Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
- Any medical reason why ssNPA therapy may not be suitable
- Active COVID 19 infections Moderate/severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
- Being tested
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Keywords
- Self-Supporting Nasopharyngeal Airway (ssNPA), Sleep study, Difficulty breathing, Obstructive Sleep Apnea, Cerebral Palsy, Down syndrome, Trisomy 21
- Medical subject headings
- Muscle Hypotonia, Sleep Apnea, Obstructive, Nasal Obstruction, Dyspnea, Cerebral Palsy, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Supporting Nasopharyngeal Airway (ssNPA)Device
The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open.
In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.
| Study group | Role | What they receive |
|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA) | Experimental | Participants will use the device up to 24 months. Receives: Device: Self-Supporting Nasopharyngeal Airway (ssNPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
Device efficacy will be measured by apnea/hypopnea index.
Measured: Approximately 1 year
Long term device tolerability assessed by self-report from caregivers
This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).
Measured: 2 years
Secondary outcomes (4)
Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality
This will be a on a scale 1-10 (higher score is better).
Measured: 1-2 years
Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can receive 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Measured: 1-2 years
Long-term impact on quality of life will be assessed with the OSA-18
This is an obstructive sleep apnea-specific quality of life tool for children and the Pediatric Quality of Life Inventory (PedsQL), a standard health-related quality of life instrument. Scores range from 0-126 with higher scores indicting worse impact. There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total quality of life score is the sum of all the items over the number of items answered on all scales.
Measured: 1-2 years
Family Impact Questionnaire (FIQ)
This tool measures parent's perceptions of the child's negative impact on the family. The FIQ is a 50-item, four-point Likert scale ranging from 0 (not at all) to 3 (very much) that asks about the impact the child has had on the family (e.g., social life, finances, marriage, and siblings) compared to the impact other children his/her age have on their families. Higher score is more significant impact.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start23 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotonia, MuscleStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group intervention for participants who have completed NCT05527652 (Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise O'Brien, University of Michigan
- Investigators
- Louise M O'Brien, PhD, MS, Principal investigator, University Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614582
- Sponsor's protocol ID
- HUM00239400
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Small number of complex children that could be identified by sharing Individual participant data (IPD).
Publications
Powell AR, Srinivasan S, Helman JL, Li AD, O'Brien LM, Shih A, Plott JS, Zopf DA. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation. J Clin Sleep Med. 2022 Oct 1;18(10):2497-2502. doi: 10.5664/jcsm.10202.
PubMed 35866230
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
- ClinicalTrials.gov ID
- NCT06614582
- Acronym / sponsor ID
- HUM00239400
- Keywords
- Self-Supporting Nasopharyngeal Airway (ssNPA), Sleep study, Difficulty breathing, Obstructive Sleep Apnea, Cerebral Palsy, Down syndrome, Trisomy 21
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group intervention for participants who have completed NCT05527652 (Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia)
| Arm | Type | Receives |
|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA) | Experimental | Device: Self-Supporting Nasopharyngeal Airway (ssNPA)Participants will use the device up to 24 months. |
Who may qualify
- Ages
- 3 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
- Willingness to continue device usage.
- Confirmed diagnosis of OSA (apnea/hypopnea index; AHI \> 10 or AHI \>5 with lowest oxygen level ≤75%)
- At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
- Previous adenotonsillectomy (unless tonsillectomy not possible)
Key exclusion criteria (6 listed)
- Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
- Any medical reason why ssNPA therapy may not be suitable
- Active COVID 19 infections Moderate/severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA)The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open. In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit. | Device | Self-Supporting Nasopharyngeal Airway (ssNPA) |
Primary outcome
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography
Time frame: Approximately 1 year
Device efficacy will be measured by apnea/hypopnea index.
Long term device tolerability assessed by self-report from caregivers
Time frame: 2 years
This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).
4 secondary outcomes
Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality
Time frame: 1-2 years
Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)
Time frame: 1-2 years
Long-term impact on quality of life will be assessed with the OSA-18
Time frame: 1-2 years
Family Impact Questionnaire (FIQ)
Time frame: 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 35866230Powell AR, Srinivasan S, Helman JL, Li AD, O'Brien LM, Shih A, Plott JS, Zopf DA. Novel treatment for hypotonic airway obstruction and severe obstructive sleep apnea using a nasopharyngeal airway device with 3D printing innovation. J Clin Sleep Med. 2022 Oct 1;18(10):2497-2502. doi: 10.5664/jcsm.10202.
- Individual participant dataSharing planned: No. Small number of complex children that could be identified by sharing Individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise M O'Brien, PhD, MS principal investigator
University Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Supporting Nasopharyngeal Airway (ssNPA) in people with Hypotonia, Muscle and Obstructive Sleep Apnea, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography (time frame: Approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.