Sleep Apnea, ObstructiveNCT03748771
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
A study testing ApneaLink Air in people with Sleep Apnea, Obstructive, run by ResMed at 1 site in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- ApneaLink Air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 28 Feb 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting with symptoms of OSA needing a sleep study
- Patients between the ages of 12 and 17 years, inclusive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital
San Diego, California, 92123
About this study
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..
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- ApneaLink Air
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLink AirDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ApneaLink Air | Experimental | Half of the participants will undergo HST no greater than one week prior to their in-laboratory PSG, while the other half will undergo HST no greater than one week following their in laboratory PSG. All participants will also undergo their HST concurrent to their in-laboratory PSG. The rational for splitting participants in these two groups is to equally distribute the effects of the first night evenly, in which the sleep architecture including reduced total rapid eye movement (REM) sleep time can vary during the first ever sleep study. As the HST will be compared to the in-lab PSG, we would like to evenly distribute this effect by having two groups of ten participants. Receives: Device: ApneaLink Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
Patient Satisfaction
Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: "Do you prefer HST over PSG?"
Measured: Day 1
Number of Successful HST Evaluations
An unsuccesful HST or HST failure will be defined as:
- Loss of the nasal flow channel, or thoracic or abdominal sensor
- Recordings with less than 4h of artifact-free recording time
- Less than 4h of Sp02 signal
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Dec 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748771
- Sponsor's protocol ID
- UCSD 171173
- Status last verified
- Oct 2021
- First submitted
- 12 Nov 2018
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bhattacharjee R, Benjafield A, Blase A, Dever G, Celso J, Nation J, Good R, Malhotra A. The accuracy of a portable sleep monitor to diagnose obstructive sleep apnea in adolescent patients. J Clin Sleep Med. 2021 Jul 1;17(7):1379-1387. doi: 10.5664/jcsm.9202.
PubMed 33666166