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

NCT ID: NCT02612038

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-05-01

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Expiratory resistance

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

Group Type: EXPERIMENTAL

Expiratory resistance

Intervention Type: DEVICE

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

Sham expiratory resistance

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

Group Type: SHAM_COMPARATOR

Sham expiratory resistance

Intervention Type: DEVICE

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

Interventions

Expiratory resistance

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

Intervention Type: DEVICE

Sham expiratory resistance

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

Intervention Type: DEVICE

Other Intervention Names

Expiratory positive pressure

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Andrew Wellman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Wellman, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

2012P000957E

Identifier Type: -

Identifier Source: org_study_id