NCT02612038

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

November 19, 2015

Last Update Submit

February 23, 2022

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaExpiratory flow limitation

Outcome Measures

Primary Outcomes (1)

  • Increase in ventilation (L/min) from baseline

    Acutely (1 min)

Secondary Outcomes (2)

  • Increase in time to arousal from sleep

    Acutely (1 min)

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

    Acutely (1 hour)

Other Outcomes (1)

  • Reduction in frequency of arousals from sleep

    Acutely (1 hour)

Study Arms (2)

Expiratory resistance

EXPERIMENTAL

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

Device: Expiratory resistance

Sham expiratory resistance

SHAM COMPARATOR

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

Device: Sham expiratory resistance

Interventions

Expiratory resistanceDEVICE

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

Also known as: Expiratory positive pressure
Expiratory resistance
Sham expiratory resistanceDEVICE

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

Sham expiratory resistance

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of obstructive sleep apnea (AHI\>10/hr)

You may not qualify if:

  • Serious co-morbidities including lung disease, heart disease, renal disease
  • Medications affecting respiration or sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Andrew Wellman, PhD MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 23, 2015

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 9, 2022

Record last verified: 2022-02