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Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03189173
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Monash University
American Heart Association
National Heart, Lung, and Blood Institute (NHLBI)
Heart Foundation of Australia
Information provided by (Responsible Party):
Scott Aaron Sands, Brigham and Women's Hospital

Brief Summary:

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested:

Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance.

Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Oral appliance Drug: Oxygen Other: Oral appliance plus oxygen Other: No treatment Phase 2

Detailed Description:

Pre-specified primary analysis for Aim 1 is the change in AHI with combination treatment versus oral appliance alone (%reduction versus placebo; including hypopnea events without desaturation/arousals).

Aim 2 seeks to identify subgroups of patients that have the greatest reduction in AHI (responders) with each treatment (post-hoc). We will use baseline physiological measures of the four traits causing OSA (collapsibility, responsiveness, loop gain, arousal threshold) to determine which characteristics predict responses to each intervention (leave-one-out support vector machine modeling). Clinical measures of the same traits will be estimated from the placebo night to confirm that responses can be predicted with clinically-available data. We will also test whether responders to oral appliances have a greater response to oxygen than oral appliance non-responders (and vice-versa), to address whether responders to both treatments are similar or different.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will receive mandibular advancement, supplemental oxygen, mandibular advancement plus supplemental oxygen, and no treatment in randomized order. On nights without supplemental oxygen, subjects will be administered sham (air, single blinded). Oral appliance use will not be masked.
Masking: None (Open Label)
Masking Description: Supplemental oxygen versus air assignment nights will be blinded to participants, but will be known by the investigator. Oral appliances will be "open label".
Primary Purpose: Treatment
Official Title: Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: All patients

Patients will receive all four interventions in randomized order.

Note: Data will not be analyzed separately for the 16 cross-over combinations of intervention order:

Interventions: Oral appliance | Oral appliance plus oxygen | Oxygen | No treatment

Device: Oral appliance

An oral appliance (dental mouthpiece) will be used to improve upper airway patency. Patients who do not have their own custom dental oral appliance (various brands, commonly Herbst/Somnomed) will be provided with a device (BluePro, BlueSom) for the duration of the study.

Patients will also be administered sham (room air) at 4 L/min via nasal cannula.

Other Name: Mandibular advancement device

Drug: Oxygen
Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
Other Name: Supplemental inspired oxygen

Other: Oral appliance plus oxygen
Both treatments will be administered simultaneously.
Other Name: Combination therapy

Other: No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Other Name: Sham




Primary Outcome Measures :
  1. Change in apnea hypopnea index (AHI), percent of baseline. [ Time Frame: Single night ]
    Primary test is difference between combination therapy and oral appliance


Secondary Outcome Measures :
  1. Change in frequency of arousals, percent of baseline. [ Time Frame: Single night ]
    Primary test is difference between combination therapy and oral appliance

  2. Patient reported sleep quality (better/same/worse) [ Time Frame: Single night ]
    Primary test is difference between combination therapy and oral appliance

  3. Morning minus evening systolic blood pressure [ Time Frame: Single night ]
    Primary test is difference between combination therapy and oral appliance

  4. Morning minus evening diastolic blood pressure [ Time Frame: Single night ]
    Primary test is difference between combination therapy and oral appliance



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed OSA or suspected OSA based on snoring

Exclusion Criteria:

  • Severe co-morbidities (cardiovascular, renal, lung disease, neurological), including:

Congestive heart failure, Neurological conditions that may affect sleep or breathing (e.g. neuromuscular diseases e.g. myasthenia gravis; neurodegenerative diseases e.g. Alzheimer's/Parkinson's)

  • Medications that will substantially affect respiration, including opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine
  • Claustrophobia
  • Insomnia and other non-respiratory sleep disorders
  • Inability to sleep supine
  • Contraindications to oral appliances, including insufficient teeth to support the device, periodontal problems inducing tooth mobility, active temporomandibular joint disorder
  • Allergy to lidocaine or oxymetazoline HCl

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): NCT03189173


Contacts
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Contact: Scott A Sands, PhD 6172780911 sasands@bwh.harvard.edu
Contact: Lauren Hess 6177328976 lhess1@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Scott A Sands, PhD    857-928-0341    sasands@bwh.harvard.edu   
Australia, Victoria
Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University Not yet recruiting
Notting Hill, Victoria, Australia, 3168
Contact: Bradley A Edwards, PhD    61 3 9905 0187    bradley.edwards@monash.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Monash University
American Heart Association
National Heart, Lung, and Blood Institute (NHLBI)
Heart Foundation of Australia
Investigators
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Principal Investigator: Scott A Sands, PhD Brigham and Women's Hospital
Principal Investigator: Bradley A Edwards, PhD Monash University

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Responsible Party: Scott Aaron Sands, Associate Physiologist / Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03189173     History of Changes
Other Study ID Numbers: 2017P001037
15SDG25890059 ( Other Grant/Funding Number: American Heart Association )
R01HL128658 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Fully-deidentified subject data will be shared via an online repository.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Scott Aaron Sands, Brigham and Women's Hospital:
Obstructive Sleep Apnea
Ventilatory Control Instability
Complex Sleep Apnea
Additional relevant MeSH terms:
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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