ASV Therapy for Insomnia | NCT07011966

Studies
ASV Therapy for Insomnia

NCT07011966

Sponsor

ResMed

Status

Recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Insomnia
Insomnia (Moderate)

Interventions

ASV therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jun 2, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2026

Last Update Posted Date

May 19, 2026Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASV Therapy	Experimental		Device: ASV therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sleep Onset Latency	Change in from baseline to end of treatment in sleep onset time	4 weeks after treatment initiation

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D008224	Lymphoma, Follicular

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases