Sleep Apnea, Obstructive
Conditions
Brief summary
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..
Detailed description
Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to 10% of obese children. The reported prevalence is likely underestimated due to the lack of available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in a significant strain for in laboratory PSG including children in the greater San Diego county. Currently, HST in children is restricted based on the limited availability of HST devices on children that have attained clearance by the US Food and Drug Administration (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians. Adolescent children will be recruited whose clinically indicated in laboratory PSG will be performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink Air HST at home following their sleep study within one week, and the remaining ten children will have their ApneaLink Air HST performed within one week prior to their in laboratory clinically indicated PSG.
Interventions
DEVICEApneaLink Air
The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with symptoms of OSA needing a sleep study * Patients between the ages of 12 and 17 years, inclusive
Exclusion criteria
* Patients less than 12 years old * Patients 18 years old or older * Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, children with craniofacial disorders, and finally children with congenital heart disease or pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Day 1 | Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: Do you prefer HST over PSG? |
| Number of Successful HST Evaluations | Day 1 | An 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ApneaLink Air Cohort Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | ApneaLink Air Cohort |
|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 1.72 |
| BMI | 32 kg/square meters STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized Hispanic | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 7 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
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
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ApneaLink Air Cohort | Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | AHI from HST | 6.2 events per hour | Standard Deviation 10.7 |
| ApneaLink Air Cohort | Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | ODI from HST | 10.9 events per hour | Standard Deviation 11.4 |
| ApneaLink Air Cohort | Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | AHI from ALT | 11.6 events per hour | Standard Deviation 21.8 |
| ApneaLink Air Cohort | Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | ODI from ALT | 16.9 events per hour | Standard Deviation 24 |
| ApneaLink Air Cohort | Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) | AHI from PSG | 18.6 events per hour | Standard Deviation 35.8 |
| ApneaLink Air Cohort | 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
Number of Successful HST Evaluations
An 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
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ApneaLink Air Cohort | Number of Successful HST Evaluations | Successful HST | 15 Participants |
| ApneaLink Air Cohort | Number of Successful HST Evaluations | Successful ALT | 17 Participants |
Secondary
Patient Satisfaction
Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: Do you prefer HST over PSG?
Time frame: Day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ApneaLink Air Cohort | Patient Satisfaction | Yes | 12 Participants |
| ApneaLink Air Cohort | Patient Satisfaction | No | 4 Participants |
| ApneaLink Air Cohort | Patient Satisfaction | No Difference | 1 Participants |