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Completed

NCT Number: NCT03473548

Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 5- to 12-years-old
  • Parental informed consent
  • Suspected Sleep Disordered Breathing

Exclusion criteria

  • 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)

Treatment and study plan

Portable sleep monitor

Device

Type III at home portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Apnea Hypopnea Index (AHI) Score

    Time frame: greater than or equal to 6 hours

    Number of participants with Apnea Hypopnea Index (AHI) score

  2. SPO2 Result

    Time frame: greater than or equal to 6 hours

    Number of Participants with an SPO2 result

  3. SPO2 Nadir

    Time frame: greater than or equal to 6 hours

    Number of participants with an SPO2 nadir

  4. McGill Oximetry Score

    Time frame: greater than or equal to 6 hours

    Number of participants with McGill Oximetry Score

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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