Trial Outcomes & Findings for Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients (NCT NCT03473548)
NCT ID: NCT03473548
Last Updated: 2024-02-07
Results Overview
Feasibility of obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index using un-attended polysomnography; polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined; \<5=Normal (no Sleep Apnea); 5-15=Mild Sleep Apnea; 15-30=Moderate Sleep Apnea; \>30 Severe Sleep Apnea
COMPLETED
NA
11 participants
greater than or equal to 6 hours
2024-02-07
Participant Flow
Patients and their families who present to the Washington University Department of Pediatric Otolaryngology with a suspected diagnosis of sleep disordered breathing was given information regarding the study in the office.
Participant milestones
| Measure |
Portable Sleep Monitor
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
In-laboratory Polysomnography
Polysomnography testing will determine the sleep stages, apnea hypopnea index (AHI), blood saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation. A McGill Oximetry Score will also be calculated for the in-laboratory PSG.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
0
|
|
Overall Study
COMPLETED
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Portable Sleep Monitor
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
In-laboratory Polysomnography
Polysomnography testing will determine the sleep stages, apnea hypopnea index (AHI), blood saturation oxygen nadir (SPO2 nadir), and average blood oxygen saturation. A McGill Oximetry Score will also be calculated for the in-laboratory PSG.
|
|---|---|---|
|
Overall Study
Did not attempt HST testing
|
3
|
0
|
Baseline Characteristics
One 1 out of 10 participants had \> 6 hours of HST recording and \> 6 hours of in lab polysomnography
Baseline characteristics by cohort
| Measure |
In Lab Polysomnography
n=11 Participants
All eligible subjects will have in-laboratory polysomnography as is routinely performed in the diagnostic work up for suspected sleep disordered breathing. The in-laboratory sleep study will be done at the St. Louis Children's Hospital Pediatric Sleep Center, which is an American Academy of Sleep Medicine accredited sleep disorder center. The Center is sound-proof, and has been designed to provide as natural and home-like an atmosphere as possible. Infrared monitoring equipment allows for patient observation from outside of the patient's sleep room. At least one parent is required to stay in the room overnight with the patient. A second parent can stay as well, but not required. The Center is located inside of St. Louis Children's Hospital within an inpatient medical unit, which is staffed with physicians and nurses 24 hours per day
|
|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7 years
STANDARD_DEVIATION 0 • n=5 Participants • One 1 out of 10 participants had \> 6 hours of HST recording and \> 6 hours of in lab polysomnography
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: greater than or equal to 6 hoursPopulation: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography
Feasibility of obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index using un-attended polysomnography; polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined; \<5=Normal (no Sleep Apnea); 5-15=Mild Sleep Apnea; 15-30=Moderate Sleep Apnea; \>30 Severe Sleep Apnea
Outcome measures
| Measure |
Portable Sleep Monitor
n=1 Participants
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
|---|---|
|
Greater Than or Equal to 6 Hours of Sleep Data
|
1 Participants
|
SECONDARY outcome
Timeframe: greater than or equal to 6 hoursPopulation: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography
Number of participants with Apnea Hypopnea Index (AHI) score
Outcome measures
| Measure |
Portable Sleep Monitor
n=1 Participants
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
|---|---|
|
Apnea Hypopnea Index (AHI) Score
|
1 Participants
|
SECONDARY outcome
Timeframe: greater than or equal to 6 hoursPopulation: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography
Number of Participants with an SPO2 result
Outcome measures
| Measure |
Portable Sleep Monitor
n=1 Participants
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
|---|---|
|
SPO2 Result
|
1 Participants
|
SECONDARY outcome
Timeframe: greater than or equal to 6 hoursPopulation: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography
Number of participants with an SPO2 nadir
Outcome measures
| Measure |
Portable Sleep Monitor
n=1 Participants
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
|---|---|
|
SPO2 Nadir
|
1 Participants
|
SECONDARY outcome
Timeframe: greater than or equal to 6 hoursPopulation: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography
Number of participants with McGill Oximetry Score
Outcome measures
| Measure |
Portable Sleep Monitor
n=1 Participants
Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
Portable sleep monitor: Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
|
|---|---|
|
McGill Oximetry Score
|
1 Participants
|
Adverse Events
Portable Sleep Monitor
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