Trial Outcomes & Findings for Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children (NCT NCT03748771)
NCT ID: NCT03748771
Last Updated: 2021-11-15
Results Overview
Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index) The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep. The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour
COMPLETED
20 participants
Day 1
2021-11-15
Participant Flow
Participant milestones
| Measure |
ApneaLink Air Cohort
Patients underwent HST no greater than one week prior to or following their in-lab PSG.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Baseline characteristics by cohort
| Measure |
ApneaLink Air Cohort
n=20 Participants
Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
|
|---|---|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.72 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
|
BMI
|
32 kg/square meters
STANDARD_DEVIATION 10.7 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index) The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep. The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour
Outcome measures
| Measure |
ApneaLink Air Cohort
n=20 Participants
Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
|
|---|---|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
AHI from HST
|
6.2 events per hour
Standard Deviation 10.7
|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
ODI from HST
|
10.9 events per hour
Standard Deviation 11.4
|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
AHI from ALT
|
11.6 events per hour
Standard Deviation 21.8
|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
ODI from ALT
|
16.9 events per hour
Standard Deviation 24.0
|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
AHI from PSG
|
18.6 events per hour
Standard Deviation 35.8
|
|
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
ODI from PSG
|
13.5 events per hour
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Day 1Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: "Do you prefer HST over PSG?"
Outcome measures
| Measure |
ApneaLink Air Cohort
n=17 Participants
Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
|
|---|---|
|
Patient Satisfaction
Yes
|
12 Participants
|
|
Patient Satisfaction
No
|
4 Participants
|
|
Patient Satisfaction
No Difference
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1An unsuccesful HST or HST failure will be defined as: 1. Loss of the nasal flow channel, or thoracic or abdominal sensor 2. Recordings with less than 4h of artifact-free recording time 3. Less than 4h of Sp02 signal
Outcome measures
| Measure |
ApneaLink Air Cohort
n=20 Participants
Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.
|
|---|---|
|
Number of Successful HST Evaluations
Successful HST
|
15 Participants
|
|
Number of Successful HST Evaluations
Successful ALT
|
17 Participants
|
Adverse Events
ApneaLink Air Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rakesh Bhattacharjee
University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place