NCT02489591

Brief Summary

Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete response occurs in approximately 50% of patients. In general, OA devices are designed to maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper airway obstruction. Limited studies in awake or sedated patients have demonstrated the effects of mandibular advancement on aspects of pharyngeal structure and function. The objective of the proposed research is to fully characterize upper airway collapse in OSA patients during natural sleep and use this information to understand why some patients appear to exhibit a large improvement in pharyngeal collapsibility whereas others do not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

July 14, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

June 30, 2015

Last Update Submit

February 23, 2022

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (2)

  • Change in passive pharyngeal collapsibility (OA therapy minus control)

    The passive pressure-flow relationship is characterized by the critical closing pressure (Pcrit) , and the ventilatory flow at atmospheric pressure ( V passive). Pcrit and V passive will be determined using the standard 5-breath CPAP drop method. The change in collapsibility will be compared across subgroups defined by the site of collapse measured using sleep-endoscopy. Patients will sleep supine for this measurement.

    3 nights

  • Change in sleep apnea severity (AHI)

    The change in apnea-hypopnea index (AHI, 3% desaturation or arousal criteria; OA therapy minus control) will be compared across subgroups defined by the site of collapse measured using sleep-endoscopy. Baseline collapsibility will be incorporated as a predictor of the change in AHI.

    2 nights

Secondary Outcomes (4)

  • Change in peak flow during sleep (OA therapy minus control)

    2 nights

  • Objective sleep quality (OA therapy minus control)

    2 nights

  • Objective sleep quality (OA therapy minus control)

    2 nights

  • Subjective sleep quality (OA therapy minus control)

    2 nights

Study Arms (2)

Control

NO INTERVENTION

No oral appliance (control) first, oral appliance (BluePro oral appliance or other device) second

Oral appliance

EXPERIMENTAL

oral appliance (BluePro oral appliance or other device) first, no oral appliance (control) second

Device: Oral applianceDevice: BluePro oral appliance

Interventions

Oral applianceDEVICE

Patients will bring their prescribed oral appliance.

Oral appliance
BluePro oral applianceDEVICE

Patients without a prescribed oral appliance will have a device provided for the duration of the study (BluePro, BlueSom; used for investigational purposes only). The device provided is a prefabricated thermoplastic customizable mandibular advancement splint.

Oral appliance

Eligibility Criteria

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

You may qualify if:

  • Patients with Obstructive Sleep Apnea

You may not qualify if:

  • Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
  • Any medication known to influence breathing, sleep/arousal or muscle physiology
  • Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
  • Claustrophobia
  • Inability to sleep supine
  • Periodontal disease and/or insufficient number of teeth
  • Allergy to lidocaine or oxymetazoline hydrochloride
  • For women: Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • David A Wellman, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 3, 2015

Study Start

July 14, 2015

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

US(1)