Sleep Apnea, ObstructiveNCT03473548
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
A study testing Portable sleep monitor and In-laboratory Polysomnography in people with Sleep Apnea, Obstructive, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Portable sleep monitor and In-laboratory Polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2017to 14 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5- to 12-years-old
- Parental informed consent
- Suspected Sleep Disordered Breathing
Who cannot join
- Developmental delay
- Use of home oxygen
- History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism)
- History of tracheal surgery
- History of tracheal stenosis
- History of Nocturnal Hypoventilation
- History of Central Sleep Apnea
- Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation)
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.
Read the detailed description
The purpose of the study proposed is twofold. First Investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. Second, Investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center. These comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the Washington University Pediatric Otolaryngology Department. Investigators will obtain the medical history and medications and results of the sleep study done at SLCH sleep lab from the medical record for research purposes.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Portable sleep monitor, In-laboratory Polysomnography
- Keywords
- Childhood OSA
- 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.
Portable sleep monitorDevice
Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis
In-laboratory PolysomnographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Unmonitored Polysomnography | Experimental | All eligible subjects will be asked to conduct an unattended, overnight sleep study performed in their home prior to in-laboratory polysomnography, using a standard Type III portable monitor. The type III portable sleep 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. Receives: Device: Portable sleep monitor |
| In-laboratory Polysomnography | Active comparator | All eligible subjects will have in-laboratory polysomnography as is routinely performed in the diagnostic work up for suspected sleep disordered breathing. Receives: Other: In-laboratory Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater Than or Equal to 6 Hours of Sleep Data
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
Measured: greater than or equal to 6 hours
Secondary outcomes (4)
Apnea Hypopnea Index (AHI) Score
Number of participants with Apnea Hypopnea Index (AHI) score
Measured: greater than or equal to 6 hours
SPO2 Result
Number of Participants with an SPO2 result
Measured: greater than or equal to 6 hours
SPO2 Nadir
Number of participants with an SPO2 nadir
Measured: greater than or equal to 6 hours
McGill Oximetry Score
Number of participants with McGill Oximetry Score
Measured: greater than or equal to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start28 Dec 2017
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
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.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Leonard, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473548
- Sponsor's protocol ID
- 201710103
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2018
- Last updated
- 7 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03473548
- Acronym / sponsor ID
- 201710103
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Childhood OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 7 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.
Detailed description
The purpose of the study proposed is twofold. First Investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. Second, Investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center. These comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the Washington University Pediatric Otolaryngology Department. Investigators will obtain the medical history and medications and results of the sleep study done at SLCH sleep lab from the medical record for research purposes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Unmonitored Polysomnography | Experimental | Device: Portable sleep monitorAll eligible subjects will be asked to conduct an unattended, overnight sleep study performed in their home prior to in-laboratory polysomnography, using a standard Type III portable monitor. The type III portable sleep 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 | Active comparator | Other: In-laboratory PolysomnographyAll eligible subjects will have in-laboratory polysomnography as is routinely performed in the diagnostic work up for suspected sleep disordered breathing. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 5- to 12-years-old
- Parental informed consent
- Suspected Sleep Disordered Breathing
Key exclusion criteria (8 listed)
- Developmental delay
- Use of home oxygen
- History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism)
- History of tracheal surgery
- History of tracheal stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable sleep monitorType III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis | Device | Unmonitored Polysomnography |
| In-laboratory PolysomnographyPolysomnography 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. | Other | In-laboratory Polysomnography |
Primary outcome
Greater Than or Equal to 6 Hours of Sleep Data
Time frame: greater than or equal to 6 hours
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
4 secondary outcomes
Apnea Hypopnea Index (AHI) Score
Time frame: greater than or equal to 6 hours
SPO2 Result
Time frame: greater than or equal to 6 hours
SPO2 Nadir
Time frame: greater than or equal to 6 hours
McGill Oximetry Score
Time frame: greater than or equal to 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Leonard, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable sleep monitor and In-laboratory Polysomnography in people with Sleep Apnea, Obstructive, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greater Than or Equal to 6 Hours of Sleep Data (time frame: greater than or equal to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.