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

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Mass General Brigham

Status and phase

Completed
Phase 2

Conditions

Obstructive Sleep Apnea

Treatments

Device: Oral appliance
Other: Oral appliance plus oxygen
Drug: Oxygen
Other: No treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03189173
R01HL128658 (U.S. NIH Grant/Contract)
15SDG25890059 (Other Grant/Funding Number)
2017P001037

Details and patient eligibility

About

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.

Full 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.

Read more

Enrollment

41 patients

Sex

All

Ages

21 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

41 participants in 20 patient groups

Combo, Mad, Sham, Oxygen
Experimental group
Description:
Order of interventions: Combo, Mad, Sham, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Combo, Oxygen, Mad, Sham
Experimental group
Description:
Order of interventions: Combo, Oxygen, Mad, Sham
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Combo, Oxygen, Sham, MAD
Experimental group
Description:
Order of interventions: Combo, Oxygen, Sham, MAD
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Combo, Sham, Mad, Oxygen
Experimental group
Description:
Order of interventions: Combo, Sham, Mad, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Combo, Sham, Oxygen, MAD
Experimental group
Description:
Order of interventions: Combo, Sham, Oxygen, MAD
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Combo, Oxygen, Sham
Experimental group
Description:
Order of interventions: MAD, Combo, Oxygen, Sham
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Combo, Sham, Oxygen
Experimental group
Description:
Order of interventions: MAD, Combo, Sham, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Oxygen, Combo, Sham
Experimental group
Description:
Order of interventions: MAD, Oxygen, Combo, Sham
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Oxygen, Sham, Combo
Experimental group
Description:
Order of interventions: MAD, Oxygen, Sham, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Sham, Combo, Oxygen
Experimental group
Description:
Order of interventions: MAD, Sham, Combo, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
MAD, Sham, Oxygen, Combo
Experimental group
Description:
Order of interventions: MAD, Sham, Oxygen, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Oxygen, Combo, Sham, MAD
Experimental group
Description:
Order of interventions: Oxygen, Combo, Sham, MAD
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Oxygen, MAD, Sham, Combo
Experimental group
Description:
Order of interventions: Oxygen, MAD, Sham, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Oxygen, Sham, Combo, MAD
Experimental group
Description:
Order of interventions: Oxygen, Sham, Combo, MAD
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Oxygen, Sham, MAD, Combo
Experimental group
Description:
Order of interventions: Oxygen, Sham, MAD, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Sham, Combo, MAD, Oxygen
Experimental group
Description:
Order of interventions: Sham, Combo, MAD, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Sham, MAD, Combo, Oxygen
Experimental group
Description:
Order of interventions: Sham, MAD, Combo, Oxygen
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Sham, MAD, Oxygen, Combo
Experimental group
Description:
Order of interventions: Sham, MAD, Oxygen, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Sham, Oxygen, Combo, MAD
Experimental group
Description:
Order of interventions: Sham, Oxygen, Combo, MAD
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance
Sham, Oxygen, MAD, Combo
Experimental group
Description:
Order of interventions: Sham, Oxygen, MAD, Combo
Treatment:
Other: No treatment
Drug: Oxygen
Other: Oral appliance plus oxygen
Device: Oral appliance

Trial contacts and locations

2

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Central trial contact

Scott A Sands, PhD; Lauren Hess

Data sourced from clinicaltrials.gov

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