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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03189173
Ethics application status
Date submitted
14/06/2017
Date registered
16/06/2017

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: Combo, Mad, Sham, Oxygen - Order of interventions: Combo, Mad, Sham, Oxygen

Experimental: Combo, Oxygen, Mad, Sham - Order of interventions: Combo, Oxygen, Mad, Sham

Experimental: Combo, Oxygen, Sham, MAD - Order of interventions: Combo, Oxygen, Sham, MAD

Experimental: Combo, Sham, Mad, Oxygen - Order of interventions: Combo, Sham, Mad, Oxygen

Experimental: Combo, Sham, Oxygen, MAD - Order of interventions: Combo, Sham, Oxygen, MAD

Experimental: MAD, Combo, Oxygen, Sham - Order of interventions: MAD, Combo, Oxygen, Sham

Experimental: MAD, Combo, Sham, Oxygen - Order of interventions: MAD, Combo, Sham, Oxygen

Experimental: MAD, Oxygen, Combo, Sham - Order of interventions: MAD, Oxygen, Combo, Sham

Experimental: MAD, Oxygen, Sham, Combo - Order of interventions: MAD, Oxygen, Sham, Combo

Experimental: MAD, Sham, Combo, Oxygen - Order of interventions: MAD, Sham, Combo, Oxygen

Experimental: MAD, Sham, Oxygen, Combo - Order of interventions: MAD, Sham, Oxygen, Combo

Experimental: Oxygen, Combo, Sham, MAD - Order of interventions: Oxygen, Combo, Sham, MAD

Experimental: Oxygen, MAD, Sham, Combo - Order of interventions: Oxygen, MAD, Sham, Combo

Experimental: Oxygen, Sham, Combo, MAD - Order of interventions: Oxygen, Sham, Combo, MAD

Experimental: Oxygen, Sham, MAD, Combo - Order of interventions: Oxygen, Sham, MAD, Combo

Experimental: Sham, Combo, MAD, Oxygen - Order of interventions: Sham, Combo, MAD, Oxygen

Experimental: Sham, MAD, Combo, Oxygen - Order of interventions: Sham, MAD, Combo, Oxygen

Experimental: Sham, MAD, Oxygen, Combo - Order of interventions: Sham, MAD, Oxygen, Combo

Experimental: Sham, Oxygen, Combo, MAD - Order of interventions: Sham, Oxygen, Combo, MAD

Experimental: Sham, Oxygen, MAD, Combo - Order of interventions: Sham, Oxygen, MAD, Combo


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.
Assessment method [1] 0 0
Primary test is difference between combination therapy and oral appliance
Timepoint [1] 0 0
Single night
Secondary outcome [1] 0 0
Change in frequency of arousals, percent of baseline.
Assessment method [1] 0 0
Primary test is difference between combination therapy and oral appliance
Timepoint [1] 0 0
Single night
Secondary outcome [2] 0 0
Patient reported sleep quality (visual analog scale)
Assessment method [2] 0 0
Primary test is difference between combination therapy and oral appliance
Timepoint [2] 0 0
Single night
Secondary outcome [3] 0 0
Morning minus evening systolic blood pressure
Assessment method [3] 0 0
Primary test is difference between combination therapy and oral appliance
Timepoint [3] 0 0
Single night
Secondary outcome [4] 0 0
Morning minus evening diastolic blood pressure
Assessment method [4] 0 0
Primary test is difference between combination therapy and oral appliance
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
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Actual
1/05/2023
Sample size
Target
Accrual to date
Final
41
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
American Heart Association
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Heart Foundation of Australia
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03189173