Obese for Obesity

N/A

Waitlist Available

Led By Indra Narang, BMEDSci, MBBCH, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1-4

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing heated humidified high-flow air (HHF) as a treatment for patients with Obstructive Sleep Apnea (OSA). HHF delivers warm, moist air through the nose to help keep the airways open and reduce breathing interruptions during sleep. Heated humidification has been shown to reduce nasal symptoms and improve initial use in patients with obstructive sleep apnea (OSA).

Eligible Conditions

Obesity
Sleep Apnea
Central Sleep Apnea

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1-4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1-4

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1-4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP

Secondary study objectives

Comparative COMFORT scales with HHF and CPAP.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: ObeseActive Control1 Intervention

Obese subjects ages 10-18 years with OSA will be recruited from sleep clinic. As per standard clinic care, once a subject is diagnosed with OSA on a PSG they are reviewed in sleep clinic to discuss CPAP therapy. Families will be approached to participate in this study during the subject's regularly scheduled clinical visit. Obese subjects meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in the study.

Group II: CMCActive Control1 Intervention

As per current standard clinical care, CMC diagnosed with moderate to severe OSA following a clinically indicated baseline PSG who have had a previous adenotonsillectomy or who are not considered candidates for surgery are reviewed in sleep clinic to discuss the prescription of CPAP for OSA. CMC subjects' meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in this study.

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