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Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02489591
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Oral appliance Device: BluePro oral appliance Not Applicable

Detailed Description:
OSA patients will undergo a baseline sleep endoscopy study to identify the site of pharyngeal collapse. Subsequently, they will undergo two clinical polysomnographies (PSGs) to measure the effect of an oral appliance (a site specific therapy) on upper airway collapsibility and sleep apnea severity. During the first hour of each clinical PSG, the passive pharyngeal collapsibility will be determined using the standard 5-breath continuous positive airway pressure (CPAP) drop method. During the remainder of the night, patients will be monitored to determine sleep apnea severity (apnea-hypopnea index). These measurements will allow the investigators to determine which pharyngeal collapsing site responds best (both in terms of collapsibility and AHI) to mandibular advancement with an oral appliance. Patients who have their own oral appliance will be recruited. In addition, patients without an oral appliance will be provided with a temporary oral appliance for the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterizing Site and Severity of Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Sleep Apnea

Arm Intervention/treatment
No Intervention: Control
No oral appliance (control) first, oral appliance (BluePro oral appliance or other device) second
Experimental: Oral appliance
oral appliance (BluePro oral appliance or other device) first, no oral appliance (control) second
Device: Oral appliance
Patients will bring their prescribed oral appliance.

Device: BluePro oral appliance
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.




Primary Outcome Measures :
  1. Change in passive pharyngeal collapsibility (OA therapy minus control) [ Time Frame: 3 nights ]

    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.


  2. Change in sleep apnea severity (AHI) [ Time Frame: 2 nights ]
    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.


Secondary Outcome Measures :
  1. Change in peak flow during sleep (OA therapy minus control) [ Time Frame: 2 nights ]
    During the portion of the night dedicated to measuring sleep apnea severity, peak flow will also be measured during sleep to quantify activated upper airway collapsibility.

  2. Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]
    Arousal index, one of the standard measures of sleep quality, will be assessed.

  3. Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]
    Proportion of sleep in Non rapid eyes movement ( NREM) stage 1,one of the standard measures of sleep quality, will be assessed.

  4. Subjective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]
    Patients will rate whether they slept better/worse/same with the OA vs control.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Obstructive Sleep Apnea

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489591


Contacts
Contact: Lauren B Hess, BS (617) 732-8976 lhess1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lauren B Hess, BS    617-732-8976    lhess1@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: David A Wellman, PhD Brigham and Women's Hospital

Responsible Party: David Andrew Wellman, Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02489591     History of Changes
Other Study ID Numbers: 2012P000957
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases