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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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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

Study Design


Intervention

Device:
Expiratory resistance
Generic expiratory resistance will be added to the patient's respiratory circuit
Sham expiratory resistance
Sham expiratory resistance will be added to the patient's respiratory circuit

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Reduction in frequency of arousals from sleep Acutely (1 hour)
Primary Increase in ventilation (L/min) from baseline Acutely (1 min)
Secondary Increase in time to arousal from sleep Acutely (1 min)
Secondary Reduction in frequency of respiratory events (apnea-hypopnea index, 3% desat/arousal; NREM supine) Acutely (1 hour)
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