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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03892772




Registration number
NCT03892772
Ethics application status
Date submitted
26/03/2019
Date registered
27/03/2019

Titles & IDs
Public title
Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea
Scientific title
Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea
Secondary ID [1] 0 0
2019P000421
Universal Trial Number (UTN)
Trial acronym
ComboPlus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Drugs - SAS0421a
Treatment: Drugs - SAS0421b
Treatment: Drugs - SAS0421c
Treatment: Drugs - placebo

Experimental: SAS0421a, SAS0421b and SAS0421c - Participants will take SAS0421a, SAS0421b and SAS0421c for 3 days. Half doses will be given on the first night.

Active comparator: SAS0421a and SAS0421b - Participants will take SAS0421a and SAS0421b for 3 days. Half doses will be given on the first night.

Active comparator: SAS0421c - Participants will take SAS0421c for 3 days. Half doses will be given on the first night.

Placebo comparator: Placebo - Participants will take placebos for 3 days.


Treatment: Drugs: SAS0421a
treatment will be given for 3 days

Treatment: Drugs: SAS0421b
treatment will be given for 3 days

Treatment: Drugs: SAS0421c
treatment will be given for 3 days

Treatment: Drugs: placebo
placebo will be given for 3 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea-hypopnea index [AHI]
Timepoint [1] 0 0
3 days
Secondary outcome [1] 0 0
Hypoxic Burden
Timepoint [1] 0 0
3 days
Secondary outcome [2] 0 0
Arousal Index
Timepoint [2] 0 0
3 days
Secondary outcome [3] 0 0
Visual Analog Scale for Sleep Quality
Timepoint [3] 0 0
3 days
Secondary outcome [4] 0 0
Visual Analog Scale for Waking Unrefreshed
Timepoint [4] 0 0
3 days

Eligibility
Key inclusion criteria
Inclusion criteria:

* Ages 18 - 79 years
* Suspected or diagnosed OSA
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Any uncontrolled medical condition
* Current use of the medications under investigation
* Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
* Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines).
* Current use of SNRIs/SSRIs or anticholinergic medications.
* Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
* Respiratory disorders other than sleep disordered breathing:

chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.

* Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
* Contraindications for SAS0421a and SAS0421b, including:

* hypersensitivity to SAS0421a and SAS0421b (angioedema or urticaria)
* pheochromocytoma
* use of monoamine oxidase inhibitors
* benign prostatic hypertrophy, urinary retention
* untreated narrow angle glaucoma
* bipolar disorder, mania, psychosis
* history of major depressive disorder (age<24).
* history of attempted suicide or suicidal ideation within one year prior to screening
* clinically significant constipation, gastric retention
* pre-existing seizure disorders
* clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2)
* clinically-significant liver disorders
* clinically-significant cardiovascular conditions
* severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline)
* cardiomyopathy (LVEF<50%) or heart failure
* advanced atherosclerosis
* history of cerebrovascular events
* history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
* other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
* myasthenia gravis
* pregnancy/breast-feeding
* Additional contraindications for SAS0421c, including:

* Use more than 500 mg/day of Aspirin
* Allergies to this drug class
* Adrenocortical insufficiency
* Low sodium or potassium
* hyperchloremic acidosis
* Claustrophobia
* Pregnancy or nursing

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
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
14/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/07/2021
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
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
Commercial sector/industry
Name [1] 0 0
Apnimed
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Will IPD be available? Yes What data will be shared? All IPD collected during the study, after deidentification.

When will data be available? Immediately after publication. No end date. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? Any purpose.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Immediately after publication. No end date.
Available to whom?
1-page proposals should be directed to Dr. Scott Sands (sasands@bwh.harvard.edu). To gain access, requestors will be asked to sign a data use agreement.
Available for what types of analyses?
How or where can data be obtained?


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/NCT03892772