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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03473548

Enrollment

Registered

2018-03-22

Start date

2017-12-28

Completion date

2019-10-14

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

Childhood OSA

Brief 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.

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.

Interventions

DEVICEPortable sleep monitor

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

OTHERIn-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Single-center, un-blinded, feasibility, methods comparison, and non-inferiority study

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Greater Than or Equal to 6 Hours of Sleep Data	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

Measure	Time frame	Description
Apnea Hypopnea Index (AHI) Score	greater than or equal to 6 hours	Number of participants with Apnea Hypopnea Index (AHI) score
SPO2 Result	greater than or equal to 6 hours	Number of Participants with an SPO2 result
SPO2 Nadir	greater than or equal to 6 hours	Number of participants with an SPO2 nadir
McGill Oximetry Score	greater than or equal to 6 hours	Number of participants with McGill Oximetry Score

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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	11
Total	11

Arm

Count

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

Total

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Did not attempt HST testing	3	0

Baseline characteristics

Characteristic	In Lab Polysomnography
Age, Categorical <=18 years	11 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Age, Continuous	7 years STANDARD_DEVIATION 0
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	11 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 11
other Total, other adverse events	0 / 11
serious Total, serious adverse events	0 / 11

Outcome results

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