Clinical trial NCT03188718: WatchPAT Device Validation Study Compared to Polysomnography
Official title: Validation Study of the WatchPAT 200 in the Diagnosis of Obstructive Sleep Apnea in Children 4-12 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Disorder
Sleep
Keywords: Polysomnogram
Sleep Disordered Breathing
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Itamar-Medical, Israel
First posted: 2017-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Validation study of a novel sleep Device compared to a traditional sleep study.

Detailed description: This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.

Eligibility criteria: Inclusion Criteria:

1. Age 5 through 12 years of age.
2. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:

   * snoring,
   * witnessed apneas,
   * daytime sleepiness, and
   * mouth breathing, etc.
3. Informed consent obtained.

Exclusion Criteria:

1. Medical conditions that can affect the tonometer reading such as:

   * peripheral vascular disease,
   * cyanotic heart disease,
   * systemic hypertension, and
   * sickle cell crisis.
2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:

   * autism spectrum disorder,
   * Trisomy 21, and
   * neurodevelopmental disorders.
3. History of neuromuscular malformation
4. History of current supplemental oxygen use
5. History of current vasoactive, cardiac or seizure medication use
6. Inability or unwillingness to provide informed consent

Primary outcomes:
measure: Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
timeFrame: Up to 10 hours
Secondary outcomes:
measure: Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)
timeFrame: Up to 10 hours
measure: Oxygen Desaturation Index (ODI)
timeFrame: Up to 10 hours
measure: Sleep Staging: Light and Deep
timeFrame: Up to 10 hours
measure: Oxygen Saturation
timeFrame: Up to 10 hours
measure: Heart Rate
timeFrame: Up to 10 hours
measure: Body Position
timeFrame: Up to 10 hours
measure: Sleep Time (Total)
timeFrame: Up to 10 hours
measure: Sleep Staging: REM
timeFrame: Up to 10 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michelle Sobremonte-King, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Ann Halbower, MD
role: PRINCIPAL_INVESTIGATOR
References: