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NCT Number: NCT02612038

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

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).

Why the study stopped: No funding was available for the study
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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expiratory resistance

Device

Generic expiratory resistance will be added to the patient's respiratory circuit

Other names: Expiratory positive pressure

Sham expiratory resistance

Device

Sham expiratory resistance will be added to the patient's respiratory circuit

Primary outcomes

  1. Increase in ventilation (L/min) from baseline

    Time frame: Acutely (1 min)

Secondary outcomes

  1. Increase in time to arousal from sleep

    Time frame: Acutely (1 min)

  2. Reduction in frequency of respiratory events (apnea-hypopnea index, 3% desat/arousal; NREM supine)

    Time frame: Acutely (1 hour)

Other outcomes

  1. Reduction in frequency of arousals from sleep

    Time frame: Acutely (1 hour)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: ExpFLOSA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2015
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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