ASV Therapy for Insomnia

NCT ID: NCT07011966

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-08-31

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASV Therapy

Group Type: EXPERIMENTAL

ASV therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• Complaint of insomnia when presenting at clinic
• Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
• Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
• Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB
• Owns a smartphone and is able to install an application for HSAT data syncing.
• Able to fully understand study information in English and sign informed consent

Exclusion Criteria

• Primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness
• Pregnant or planning to be pregnant
• Any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
• High risk for moderate to severe OSA based on STOP-BANG score.
• BMI > 40 kg/m2
• Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial.
• Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints.
• Daily use of opiate medications
• Known contraindications to PAP therapy as listed in the indication for use (i.e. heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤45%) and moderate to severe predominant central sleep apnea).
• Inability to pre-emptively comply with study procedures
• Patients who wish to continue using sleeping pills/hypnotics during the study
• Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

C.S. Mott Center

Detroit, Michigan, United States

Countries

United States

Central Contacts

Daniela Tellez, MPH

Role: CONTACT

daniela.tellez@resmed.com

858 264 9263

Facility Contacts

Karen Collins

Role: primary

kcollins@med.wayne.edu

313-577-8606

Other Identifiers

SLP-25-01-01

Identifier Type: -

Identifier Source: org_study_id