Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation (ExpFLOSA)
Primary Purpose
Obstructive Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expiratory resistance
Sham expiratory resistance
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Expiratory flow limitation
Eligibility Criteria
Inclusion Criteria:
- Presence of obstructive sleep apnea (AHI>10/hr)
Exclusion Criteria:
- Serious co-morbidities including lung disease, heart disease, renal disease
- Medications affecting respiration or sleep
Expiratory flow limitation (EFL) subgroup inclusion criteria: presence of clear EFL on polysomnographic study (reduced flow and increased pharyngeal pressure during expiration as a predominant cause of airflow obstruction).
non-EFL subgroup inclusion criteria: complete absence of EFL on polysomnographic study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Expiratory resistance
Sham expiratory resistance
Arm Description
Generic expiratory resistance will be added to the patient's respiratory circuit
Sham resistance will be added to the patient's respiratory circuit
Outcomes
Primary Outcome Measures
Increase in ventilation (L/min) from baseline
Secondary Outcome Measures
Increase in time to arousal from sleep
Reduction in frequency of respiratory events (apnea-hypopnea index, 3% desat/arousal; NREM supine)
Full Information
NCT ID
NCT02612038
First Posted
November 19, 2015
Last Updated
February 23, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02612038
Brief Title
Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation
Acronym
ExpFLOSA
Official Title
Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
No funding was available for the study
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Expiratory flow limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expiratory resistance
Arm Type
Experimental
Arm Description
Generic expiratory resistance will be added to the patient's respiratory circuit
Arm Title
Sham expiratory resistance
Arm Type
Sham Comparator
Arm Description
Sham resistance will be added to the patient's respiratory circuit
Intervention Type
Device
Intervention Name(s)
Expiratory resistance
Other Intervention Name(s)
Expiratory positive pressure
Intervention Description
Generic expiratory resistance will be added to the patient's respiratory circuit
Intervention Type
Device
Intervention Name(s)
Sham expiratory resistance
Intervention Description
Sham expiratory resistance will be added to the patient's respiratory circuit
Primary Outcome Measure Information:
Title
Increase in ventilation (L/min) from baseline
Time Frame
Acutely (1 min)
Secondary Outcome Measure Information:
Title
Increase in time to arousal from sleep
Time Frame
Acutely (1 min)
Title
Reduction in frequency of respiratory events (apnea-hypopnea index, 3% desat/arousal; NREM supine)
Time Frame
Acutely (1 hour)
Other Pre-specified Outcome Measures:
Title
Reduction in frequency of arousals from sleep
Time Frame
Acutely (1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of obstructive sleep apnea (AHI>10/hr)
Exclusion Criteria:
Serious co-morbidities including lung disease, heart disease, renal disease
Medications affecting respiration or sleep
Expiratory flow limitation (EFL) subgroup inclusion criteria: presence of clear EFL on polysomnographic study (reduced flow and increased pharyngeal pressure during expiration as a predominant cause of airflow obstruction).
non-EFL subgroup inclusion criteria: complete absence of EFL on polysomnographic study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Wellman, PhD MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation
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