Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT02612038 |
Other study ID # |
2012P000957E |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2016 |
Est. completion date |
May 1, 2017 |
Study information
Verified date |
February 2022 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Obstructive sleep apnea (OSA) is inherently site-specific. In a physiological controlled
intervention study, the investigators seek to determine whether applying expiratory
resistance can acutely improve ventilation and sleep in patients with expiratory flow
limitation (EFL).
Description:
Collapse of the upper airway can occur at different sites of the pharynx. One common and
recognizable form of pharyngeal collapse is prolapse of the soft palate (velopharynx) on
expiration, a phenomenon referred to as expiratory flow limitation (EFL). In principle,
application of nasal positive expiratory pressure should reverse expiratory narrowing,
increase ventilation, and prevent the subsequent progressive loss of airflow that leads to
arousal from sleep, thereby improving OSA. One means to achieve this expiratory pressure is
with the use of an added nasal expiratory resistance.
Accordingly, during a single night protocol, the investigators will examine the effects of
increasing nasal expiratory resistance during sleep. During obstructed breathing, patients
will be switched acutely, in random order, from normal conditions to an added expiratory
resistance (30-80 cmH2O/L.s) or a sham resistance, for short (1 min) and prolonged periods (1
hour), repeatedly overnight.
Patients participating in the study will be divided into two groups, those exhibiting EFL
versus those without EFL (i.e. with inspiratory flow limitation).
The main outcomes of the short physiologic interventions are:
- Increase in ventilation, and
- Increased time to a respiratory-related arousal from sleep, relative to sham conditions.
The main outcome of the prolonged interventions is:
--Reduced frequency of respiratory events (AHI; 3% desaturation or arousal) relative to sham
conditions.
The central objective of the study is to test whether there is a greater improvement in the
above outcomes in those with EFL versus those without EFL.
This data will allow us to test whether expiratory resistance is of potential therapeutic
benefit specifically in patients with EFL rather than those without EFL.