Conventional Heated Humidity in Patients Using Continuous Positive Airway Pressure (CPAP)

The effects (on patient utilization and sleep quality) of Conventional Heated Humidity in Patients Using Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea(OSA) on mask on time; sleep parameters; nasal symptoms and quality of life.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000334505

Acronym

TS-HAMAa

Enrollment

Registered

2006-08-08

Start date

2006-04-01

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

Participants will be randomised to 4 weeks of CPAP with Conventional Humidification (CH) or 4 weeks of CPAP with ThermoSmart Humidification. Once completed participants will be swapped to the alternate treatment arm. Sleep Quality via Actigraphy - designed to measure rest/activity cycles continuously throughout the 24-hr day. The instrument provides reliable and valid data regarding a number of sleep-related parameters, including Total Sleep Time (TST), (awake time spent awake after sleep onset (WASO) and Sleep Efficicney (SE) A 7 day period of actigraphy will be completed in the 7 days leading up to the participants first treatment. For the first week (7 days) of each arm actigraph data will be collected. Both trial administrator and subjects will be blinded. the devices are identical looking and neither administrator nor subject will know which is which.

Interventions

4 weeks of CPAP with ThermoSmart Humidification. Once completed participants will be swapped to the alternate treatment arm. There is no washout between study arms.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

A previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.AHI = 15 OR AHI = 5 + ESS = 10 OR ESS = 10 + a medical co-morbidityPatient willing to give informed consent and follow study protocol.

Exclusion criteria

Wake resting SpO2 < 90%Patient requires BiLevel PAP or supplemental oxygenThe patient is medically unstable (e.g. respiratory or cardiac failure)Patient unwilling to give informed consent or follow study protocol.AHI: Apnea Hypopnea Index (degree of severity of OSA)ESS: Epworth Sleepiness Scale (degree of daytime sleepiness).

Outcome results