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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05350332




Registration number
NCT05350332
Ethics application status
Date submitted
22/04/2022
Date registered
28/04/2022

Titles & IDs
Public title
Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy
Scientific title
Characterizing the Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Secondary ID [1] 0 0
STUDY00003579
Universal Trial Number (UTN)
Trial acronym
DISE-Pulm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Negative Pressure Ventilator
Treatment: Devices - Pulmonary Function Testing (PFT)
Treatment: Devices - Transcutaneous Phrenic Nerve Stimulation

Experimental: Negative Pressure Ventilator - Participants with obstructive sleep apnea (OSA) who are being evaluated for surgical treatment of their OSA and having a routine clinical DISE will have their lung volume increased with a non-invasive negative pressure ventilator. Participants will also have a pulmonary function test performed per routine clinical protocol, but for research purposes only (i.e., not part of usual care).

Experimental: Transcutaneous Phrenic Nerve Stimulation - Participants with obstructive sleep apnea (OSA) who are being evaluated for surgical treatment of their OSA and having a routine clinical DISE will have their lung volume increased with transcutaneous phrenic nerve stimulation. Participants will also have a pulmonary function test performed per routine clinical protocol, but for research purposes only (i.e., not part of usual care).


Treatment: Devices: Negative Pressure Ventilator
The negative pressure ventilator is an off-the-shelf FDA-approved device designed to treat respiratory patients with hypoventilation syndromes. This ventilator places the torso within a fixed container that is connected to a vacuum source, which inflates the lungs by pulling a negative pressure around the chest and abdomen. After the clinically routine DISE, a negative pressure ventilator will be placed on the participant's chest to increase lung volumes and the DISE evaluation will be repeated to observe changes.

Treatment: Devices: Pulmonary Function Testing (PFT)
PFT is a routine standardized clinical test evaluating lung function, consisting of two parts: spirometry and body plethysmography. In spirometry, participants breathe through a mouthpiece that measures airflow and volume to determine normal and maximal volume of inspiration/expiration. Body plethysmography is performed to calculate residual lung volumes. Participants enter in an enclosed chamber where they breathe through a mouthpiece. Changes in pressure in the sealed chamber during breathing are used to calculate the volume of air that remains in the lung after expiration. A MiniBox+ device may be used. The MiniBox+ device derives total lung capacity (TLC) during tidal breathing by the analysis of gas pressures and airflows immediately preceding and immediately following airway occlusions to calculate the same measures as conventional PFT analysis.

Treatment: Devices: Transcutaneous Phrenic Nerve Stimulation
Phrenic nerve stimulation (PNS) will be performed transcutaneously using a commercially available and FDA approved peripheral neurostimulator. (Digitimer DS8R Bipolar Constant Current Stimulator). The neurostimulator consists of a stimulation generating box connected to electrodes that will be placed over the skin of the neck bilaterally over both phrenic nerves where an bipolar electric current will be used to stimulate the phrenic nerve leading to diaphragm contraction.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Expiratory Reserve Volume (ERV)
Timepoint [1] 0 0
During PFT
Primary outcome [2] 0 0
Functional Residual Capacity (FRC)
Timepoint [2] 0 0
During PFT
Primary outcome [3] 0 0
Change in VOTE Collapse Patterns - Degree of Obstruction
Timepoint [3] 0 0
During clinical DISE and intervention DISE
Primary outcome [4] 0 0
Change in VOTE Collapse Patterns - Configuration of Obstruction
Timepoint [4] 0 0
During clinical DISE and intervention DISE
Primary outcome [5] 0 0
Change in Critical Closing Pressure (Pcrit)
Timepoint [5] 0 0
During clinical DISE and intervention DISE
Primary outcome [6] 0 0
Change in Pharyngeal Opening Pressures
Timepoint [6] 0 0
During clinical DISE and intervention DISE

Eligibility
Key inclusion criteria
* Adult patients (= 18 yrs) willing and capable of providing informed consent
* Obstructive sleep apnea (AHI = 5 events/hour)
* Must be willing and able to provide informed consent to participate in the study.
* Interested in surgical treatments of OSA and have consented for a DISE procedure as part of their routine clinical evaluation.

* Patients are evaluated and cleared by anesthesia prior to the procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No significant uncontrolled medical co-morbidities (e.g., uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD).
* Any medical comorbidity that would prevent the patient from receiving anesthesia or having surgery
* Inability to tolerate negative pressure ventilator or perform PFT (i.e. claustrophobia)
* No incapacitating disability that interferes with execution of the protocol

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Other
Name
Emory University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Lunair Medical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Yu, MD
Address 0 0
Emory University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jason Yu, MD
Address 0 0
Country 0 0
Phone 0 0
470-763-3887
Fax 0 0
Email 0 0
jyu40@emory.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after deidentification will be available to share to researchers who provide a methodologically sound proposal. Sharing will be available immediately following publication with no end date.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Immediately following publication. No end date.
Available to whom?
Researchers who provide a methodologically sound proposal. Proposal should be directed to jason.lee.yu@emory.edu.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05350332