NCT04322097: DISE-CAD

Mechanisms of Upper Airway Obstruction

Completed NA Results posted Last updated 21 January 2026

What this trial tests

NA trial testing Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea in 133 participants. Completed in 10 May 2024.

Timeline

3 June 2020

Primary endpoint
10 May 2024

10 May 2024

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	133
Start date	3 June 2020
Primary completion	10 May 2024
Estimated completion	10 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Hypoglossal Nerve Stimulation

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

University of Pennsylvania

Who can join

22 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharyngeal Critical Pressure (Pcrit) Primary · Collected during drug-induced sleep endoscopy (<1 day).

Upper airway collapsibility (Pcrit, cmH₂O): Pressure at which the upper airway closes during inspiration, with a higher value indicating greater collapsibility. Pcrit less than zero indicates that the airway remains open. Pcrit greater than or equal to zero indicates that the airway is closed.

Group	Value	95% CI
Study A - Functional Phenotyping During DISE	1.26	± 3.29
Study B - HGNS Responders	-1.42	± 4.36
Study B - HGNS Nonresponders	-1.06	± 2.62

Pharyngeal Opening Pressure (PhOP) Primary · Collected during drug-induced sleep endoscopy (<1 day).

Measurement of upper airway collapsibility (cmH2O)

Group	Value	95% CI
Study A - Functional Phenotyping During DISE	7.99	± 3.45
Study B - HGNS Responders	7.33	± 3.60
Study B - HGNS Nonresponders	7.44	± 4.08

Tongue Force - Maximum Secondary · Assessed at a single visit

Tongue force was measured using the Iowa Oral Performance Instrument (IOPI) by recording the maximum pressure generated during a 2-second sustained tongue press against a bulb. Three trials were conducted and the average value was reported for all successful trials.

Group	Value	95% CI
Study B - HGNS Responders	38.0	± 18.8
Study B - HGNS Nonresponders	47.4	± 10.9

Tongue Force - Fatigue Secondary · Assessed at a single visit

Tongue fatigue was assessed by having participants apply maximum force to a pressure transducer and attempting to maintain this for 35 seconds. Data for each participant were reported as the time it takes for force to reduce by 67% of the maximum tongue force during each individual trial. Fatigue was reported as an average across up to 3 technically valid trials. Fatigue was determined by fitting a single term exponential curve to the pressure data starting at the maximal pressure (start period) and the pressure at the end of the trial.

Group	Value	95% CI
Study B - HGNS Responders	11.1	± 9.5
Study B - HGNS Nonresponders	17.1	± 12.7

Soft Palate Volume Secondary · Assessed at a single visit

Soft palate volume measured via MRI.

Group	Value	95% CI
Study B - HGNS Responders	9011.37	± 1904.12
Study B - HGNS Nonresponders	11094.10	± 2721.72

Tongue Volume Secondary · Assessed at a single visit

Tongue volume measured via MRI

Group	Value	95% CI
Study B - HGNS Responders	85131.9	± 16334.92
Study B - HGNS Nonresponders	85322.08	± 12149.09

Sponsor's own description

The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.