ASV Therapy for Insomnia

NCT07011966 | Not Yet Recruiting FDA Device

• 1 other identifier: SLP-25-01-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Insomnia (Moderate)

Keywords

Insomnia; ASV; PAP

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) score

  Change in insomnia severity from baseline to 4 weeks after treatment initiation, as measured by subjective questionnaire

  4 weeks after therapy start

Secondary Outcomes (1)

• Sleep Onset Latency

  4 weeks after treatment initiation

Study Arms (1)

ASV Therapy

EXPERIMENTAL

Device: ASV therapy

Interventions

ASV therapy 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.

ASV Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

C.S. Mott Center

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Daniela Tellez, MPH

CONTACT

858 264 9263; daniela.tellez@resmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

US (1)