Trial Outcomes & Findings for Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification (NCT NCT00681083)
NCT ID: NCT00681083
Last Updated: 2019-06-12
Results Overview
Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.
COMPLETED
NA
26 participants
End of titration night
2019-06-12
Participant Flow
Participant milestones
| Measure |
Heated Breathing Tube
Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
|
Non Heated Breathing Tube
Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
|
|---|---|---|
|
Night 1
STARTED
|
13
|
13
|
|
Night 1
COMPLETED
|
10
|
10
|
|
Night 1
NOT COMPLETED
|
3
|
3
|
|
Night 2 (Crossover of Night 1)
STARTED
|
10
|
10
|
|
Night 2 (Crossover of Night 1)
COMPLETED
|
10
|
10
|
|
Night 2 (Crossover of Night 1)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
All Study participants. Note: participants took part in both arms as it was a cross over trial
|
|---|---|
|
Age, Continuous
|
48.35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of titration nightEach night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.
Outcome measures
| Measure |
Heated Breathing Tube
n=20 Participants
Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
|
Non Heated Breathing Tube
n=20 Participants
Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
|
|---|---|---|
|
Titration Pressures After Treatment Nights
|
9.8 cmH20
Standard Deviation 1.89
|
10.9 cmH20
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: End of titration nightA correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time. This relationship was calculated for each arm and reported by a Correlation Coefficient (r score). The r score represents the strength and direction of a relationship between two variables. The value of r is always between -1 and +1. Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time. An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time. An r score of 0 indicates no relationship between the intervention and total sleep time. An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time. An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time.
Outcome measures
| Measure |
Heated Breathing Tube
n=20 Participants
Heated breathing tube (CPAP with ThermoSmart): CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
|
Non Heated Breathing Tube
n=20 Participants
Non heated breathing tube (CPAP with conventional humidification): CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
|
|---|---|---|
|
Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time
|
.535 r score
|
.058 r score
|
Adverse Events
Heated Breathing Tube
Non Heated Breathing Tube
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER