Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2008-08-31
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI \> 15/hr) during this diagnostic component will then undergo one of the following:
* Treatment with the HC254 Auto CPAP during the second half of the study.
* Treatment with the HC244 CPAP during the second half of the study.
The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.
5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
SleepStyle 254/244 CPAP series CPAP humidifier
Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SleepStyle 254/244 CPAP series CPAP humidifier
Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥18yrs of age
Exclusion Criteria
* CHF
* Co-existing obesity related hypoventilation
* Inability to give informed consent
* Patient intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate.
* Less than 3 hours in the titration period
* Under Land Transport New Zealand (LTNZ) investigation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fisher and Paykel Healthcare
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jessica Hayward, MSc
Role: PRINCIPAL_INVESTIGATOR
Fisher and Paykel Healthcare
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Auckland Hospital Sleep laboratory
Auckland, , New Zealand
Auckland Physiology Sleep Lab
Auckland, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FPHC240/250Val
Identifier Type: -
Identifier Source: org_study_id