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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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Expiratory flow limitation

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 19, 2015
    Last Updated
    February 23, 2022
    Sponsor
    Brigham and Women's Hospital
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    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

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    Nasal Expiratory Resistance in Patients With Sleep Apnea and Expiratory Flow Limitation

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