Trial Outcomes & Findings for Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia (NCT NCT04846400)

Last Updated: 2023-12-28

Results Overview

Protocol objective was to achieve a score of \>=7 in at least 60% of participants. Score of \>=7 on Likert scale 0-10 (higher score is better).

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	ssNPA self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Protocol objective was to achieve a score of \>=7 in at least 60% of participants. Score of \>=7 on Likert scale 0-10 (higher score is better).

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Ability to Tolerate Measured by Percent of Participants With Protocol Goal	50 percent of participants

PRIMARY outcome

Timeframe: 8 weeks

Protocol objective was to achieve a score of \>=6 in at least 60% of participants. Score of \>=6 on Likert scale 0-10 (higher score is better).

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Comfort as Measured by Percent of Participants With Protocol Objective Score	100 percent of participants

PRIMARY outcome

Timeframe: 8 weeks

Score of \>=5 on Likert scale 1-10 (higher score is better).

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal	100 percent of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: One participant was an inconsistent user of the device, therefore 8 week survey data is not available. Since Clinicaltrials.gov's purpose is not to show individual level results, the results for the consistent user are not shown here.

Less frequent snoring, as measured by scores of 1 or 2 on a question that read: While using the device my child's snoring occurred: 1 much less often; 2: less often; 3: unchanged; 4: more often; 5: much more

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Reduction in Epworth Sleepiness Scale score (0-24; lower score is better);

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Change in Daytime Sleepiness as Shown by Number of Participants Who Had a Reduction in Their Epworth Sleepiness Scale Score	1 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of participants whose parents' response on the sleep quality improvement question were \>=7. Change in sleep quality was reported on a 1-10 scale, where 1 was greatest worsening of sleep and 10 was most improved sleep.

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Sleep Quality, as Measured by Number of Participants With Parent Identified Improved Sleep	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

Percent of participants who reported a score of \<= 5 on Likert scale of 1-10, where lower score indicates easier insertion.

Outcome measures

Outcome measures
Measure	ssNPA n=2 Participants self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. ssNPA: The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
Insertion Protocol Optimization as Measured by Percent of Participants Who Found Insertion Relatively Easy	100 percent of participants

Adverse Events

ssNPA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David A Zopf, MD

University of Michigan

Phone: 734-936-5730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place