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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03189173




Registration number
NCT03189173
Ethics application status
Date submitted
14/06/2017
Date registered
16/06/2017
Date last updated
13/07/2023

Titles & IDs
Public title
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Scientific title
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
Secondary ID [1] 0 0
15SDG25890059
Secondary ID [2] 0 0
2017P001037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Oral appliance
Treatment: Drugs - Oxygen
Other interventions - Oral appliance plus oxygen
Other interventions - No 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


Treatment: Devices: 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.

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

Other interventions: Oral appliance plus oxygen
Both treatments will be administered simultaneously.

Other interventions: No treatment
Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in apnea hypopnea index (AHI), percent of baseline.
Timepoint [1] 0 0
Single night
Secondary outcome [1] 0 0
Change in frequency of arousals, percent of baseline.
Timepoint [1] 0 0
Single night
Secondary outcome [2] 0 0
Patient reported sleep quality (better/same/worse)
Timepoint [2] 0 0
Single night
Secondary outcome [3] 0 0
Morning minus evening systolic blood pressure
Timepoint [3] 0 0
Single night
Secondary outcome [4] 0 0
Morning minus evening diastolic blood pressure
Timepoint [4] 0 0
Single night

Eligibility
Key inclusion criteria
- Diagnosed OSA or suspected OSA based on snoring
Minimum age
21 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Sleep and Circadian Medicine Laboratory, BASE Facility, Monash University - Notting Hill
Recruitment postcode(s) [1] 0 0
3168 - Notting Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Brigham and Women's Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
American Heart Association
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Heart Foundation of Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03189173
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott A Sands, PhD
Address 0 0
Brigham and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03189173