Recruiting

Portable Sleep Monitor

Sponsor:

Lena Xiao

Code:

NCT07367022

Conditions

Autism Spectrum Disorder (ASD)

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Portable sleep monitor (Nox T3s)

Study Details

Brief summary:

The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to:

1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG);
2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA);
3. Evaluate patient and family preferences for sleep testing.

Conditions

Autism Spectrum Disorder (ASD)

Obstructive Sleep Apnea (OSA)

Study ID

NCT07367022

Start date

Aug 12, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Children between 6 to 18 years of age, AND;
2. Children diagnosed with autism spectrum disorder, AND;
3. Children who will be undergoing a polysomnogram (PSG) for the first time, AND;
4. Caregiver willing to complete questionnaires about child's sleep and behavior

Exclusion Criteria:

1. Children who are currently using respiratory therapy
2. Children who have previously completed a PSG
3. Caregiver unwilling to complete questionnaires about child's sleep and behavior

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with ASD testing a portable sleep monitor

Children aged 6-18 years old with autism spectrum disorder concurrently testing a portable sleep monitor (Nox T3s) during their first clinical polysomnogram. Children and their caregivers may also complete a qualitative interview about sleep testing preferences after their sleep test.

Interventions

Portable sleep monitor (Nox T3s)

Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.

Primary outcome measure

  • Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Lena J Xiao, MD MSc

604-875-2345lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

604-875-2345macyn.leung@bcchr.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Lena J Xiao, MD MSc

604-875-2345lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

604-875-2345macyn.leung@bcchr.ca

Principal Investigator:

Lena J Xiao, MD MSc

More Information

Sponsor

Lena Xiao

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Portable Sleep Monitor
  • Polysomnogram
  • Children with ASD
  • Nox T3s
  • Sleep Disordered Breathing
  • Sleep disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Lena Xiao on 2026-01-26.