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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03189173
• Other study ID #: 2017P001037
• Secondary ID: 15SDG25890059R01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 6, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

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

Other:
• Oral appliance plus oxygen
Both treatments will be administered simultaneously.
• No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.

Locations

Country	Name	City	State
Australia	Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University	Notting Hill	Victoria
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	American Heart Association, Heart Foundation of Australia, Monash University, National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in apnea hypopnea index (AHI), percent of baseline.	Primary test is difference between combination therapy and oral appliance	Single night
Secondary	Change in frequency of arousals, percent of baseline.	Primary test is difference between combination therapy and oral appliance	Single night
Secondary	Patient reported sleep quality (better/same/worse)	Primary test is difference between combination therapy and oral appliance	Single night
Secondary	Morning minus evening systolic blood pressure	Primary test is difference between combination therapy and oral appliance	Single night
Secondary	Morning minus evening diastolic blood pressure	Primary test is difference between combination therapy and oral appliance	Single night