NCT07011966

ASV Therapy for Insomnia

Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.

Detailed description

The primary objective of the study is to evaluate the effectiveness of adaptive servo ventilation therapy to reduce insomnia severity in primary insomnia patients.

Conditions

• Insomnia
• Insomnia (Moderate)

Interventions

Type	Name	Description
DEVICE	ASV therapy	Adaptive servo ventilation (ASV) therapy using ResMed AirCurve 11 device will be used to target potential upper airway resistance and respiratory related arousals in patients with insomnia. The ASV device is approved for the treatment of obstructive sleep apnea, and this will be designated as the investigational device for this study with appropriate labelling.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study