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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 : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE July 14, 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02489591 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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.
  • Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]
    Arousal index, one of the standard measures of sleep quality, will be assessed.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2015)
  • 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.
  • Objective sleep quality (OA therapy minus control) [ Time Frame: 2 nights ]
    Standard measures of sleep quality will be assessed, including arousal index and proportion of sleep in Non rapid eyes movement ( NREM) stage 1.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
Official Title  ICMJE Characterizing Site and Severity of Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: Oral appliance
    • Device: BluePro oral appliance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren B Hess, BS (617) 732-8976 lhess1@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489591
Other Study ID Numbers  ICMJE 2012P000957
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Andrew Wellman, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David A Wellman, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP