Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
Brief summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
Interventions
DEVICECPAP with ThermoSmart, then CPAP without ThermoSmart
CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.
DEVICECPAP without ThermoSmart, then CPAP with ThermoSmart
CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube. CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.
Sponsors
Suburban Lung Associates
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. 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. 3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity 4. Patient willing to give informed consent and follow study protocol.
Exclusion criteria
1. Wake resting SpO2 \< 90% 2. Patient requires BiLevel PAP or supplemental oxygen 3. The patient is medically unstable (e.g. respiratory or cardiac failure) 4. Patient unwilling to give informed consent or follow study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CPAP Compliance | 1, 4 & 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Subjective & Objective Sleep Parameters | 1, 4 & 8 weeks |
Countries
United States
Participant flow
Recruitment details
All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists
Participants by arm
| Arm | Count |
|---|---|
| CPAP With ThermoSmart, Then CPAP Without ThermoSmart CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.
CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. | 0 |
| CPAP Without ThermoSmart, Then CPAP With ThermoSmart CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.
CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
CPAP Compliance
Time frame: 1, 4 & 8 weeks
Population: All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists
Secondary
Subjective & Objective Sleep Parameters
Time frame: 1, 4 & 8 weeks
Population: All data from this trial has been lost. This includes all case report forms and consent forms and therefore, there are no results to report as no data exists