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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable sleep monitor | Device | Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | greater than or equal to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) Score | Number of participants with Apnea Hypopnea Index (AHI) score | greater than or equal to 6 hours |
| SPO2 Result | Number of Participants with an SPO2 result |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Leonard, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2019 | Jul 23, 2021 |
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Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study
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| In-laboratory Polysomnography | Other | 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. |
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| greater than or equal to 6 hours |
| SPO2 Nadir | Number of participants with an SPO2 nadir | greater than or equal to 6 hours |
| McGill Oximetry Score | Number of participants with McGill Oximetry Score | greater than or equal to 6 hours |
| FG001 | 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. |
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| NOT COMPLETED |
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Subjects were identified from patients presenting to the Washington University in St. Louis Pediatric Otolaryngology Clinic who are suspected of having sleep disordered breathing. All 10/11 participants completed an in lab polysomnography.
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| ID | Title | Description |
|---|---|---|
| BG000 | In Lab Polysomnography | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | One 1 out of 10 participants had > 6 hours of HST recording and > 6 hours of in lab polysomnography | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Only 1/10 participant had > 6 hours of collected data on the Home Polysomnography | Posted | Count of Participants | Participants | greater than or equal to 6 hours |
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| Secondary | Apnea Hypopnea Index (AHI) Score | Number of participants with Apnea Hypopnea Index (AHI) score | Only 1/10 participant had > 6 hours of collected data on the Home Polysomnography | Posted | Count of Participants | Participants | greater than or equal to 6 hours |
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| Secondary | SPO2 Result | Number of Participants with an SPO2 result | Only 1/10 participant had > 6 hours of collected data on the Home Polysomnography | Posted | Count of Participants | Participants | greater than or equal to 6 hours |
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| Secondary | SPO2 Nadir | Number of participants with an SPO2 nadir | Only 1/10 participant had > 6 hours of collected data on the Home Polysomnography | Posted | Count of Participants | Participants | greater than or equal to 6 hours |
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| Secondary | McGill Oximetry Score | Number of participants with McGill Oximetry Score | Only 1/10 participant had > 6 hours of collected data on the Home Polysomnography | Posted | Count of Participants | Participants | greater than or equal to 6 hours |
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Adverse event data was only collected during the HST testing and the in lab PSG testing through study completion, an average of 6 hours.
The investigator will closely monitor subjects for evidence of adverse events. All adverse events will be reported and followed until satisfactory resolution. The description of the adverse experience will include the time of onset, duration, intensity, etiology, relationship to the study (none, unlikely, possible, probable, highly probable), and any treatment required. No Adverse Events meeting the stated definitions occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Leonard | Washington University | 314-454-6162 | dsleonard@wustl.edu |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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