Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | June 2015 |
| End Date: | May 2019 |
| Contact: | Lauren B Hess, BS |
| Email: | lhess1@partners.org |
| Phone: | (617) 732-8976 |
Characterizing Site and Severity of Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea
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.
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.
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-8976
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials
