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Comparative Study of Compliance and Side Effects Under Continuous Positive Airway Pressure with Heated Humidification and Continuous Positive Airway Pressure with Heated Humidification and Additional Tube Heating.

Randomized Controlled Study of the Compliance and Side effects of Continuous Positive Airway Pressure with Heated Humidification Compared to Continuous Positive Airway Pressure with Heated Humidification with Additional Heated Breathing Tube in Patients with Obstructive Sleep Apnea.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000203459
Enrollment
70
Registered
2007-04-13
Start date
2007-01-22
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients will be recruited and randomly assigned to one of two treatment groups. Treatment group 1 will receive CPAP with a heated humidification Treatment group B will receive CPAP with heated humidification delivered via a heated breathing tube Duration: 12 months Patient compliance, quality of life and side effects of CPAP treatment will be assessed.

Interventions

Treatment group B will receive Continuous Positive Airway Pressure (CPAP) with heated humidification delivered via a heated breathing tube Dose: Pressure for each patient will be determined via a overnight polysomnography, pressure is increased until there is no longer any sleep disordered breathing or a apnea hypopnea index less than 5. Pressure range will be between 4cmH20 and 20cmH20. Duration: Subjects will use treatment at a dose prescribed to treat sleep disordered breathing every time

Treatment group B will receive Continuous Positive Airway Pressure (CPAP) with heated humidification delivered via a heated breathing tube Dose: Pressure for each patient will be determined via a overnight polysomnography, pressure is increased until there is no longer any sleep disordered breathing or a apnea hypopnea index less than 5. Pressure range will be between 4cmH20 and 20cmH20. Duration: Subjects will use treatment at a dose prescribed to treat sleep disordered breathing every time the patient sleeps for 12 months. There is no strict number of hours that the patient is required to sleep with the device, patients will use the device at each sleep session for as long as they can tolerate optimally until they awake in the morning. Range of hours will be between 0 and 12 hours usage.

Sponsors

Fisher and Paykel Healthcare Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Newly diagnosed sleep apnoea syndrome. Apnea hypopnea index (AHI) > 5/hr, accompanied by clinical symptoms of sleep apnoea. Written consent.

Exclusion criteria

No consent givenCerebral disordersPeriodic Leg Movement Syndrome (PLMS) during sleepExacerbated chronic obstructive respiratory illnessesDecompensated heart insufficiencyMalignant heart arrhythmia or uncontrolled arterial hypertoniaPregnancyMalignant illnesses.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026