ASV Therapy for Insomnia

Overseen By Daniela Tellez, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ResMed

Must not be taking: Sedatives, Psychotropics, Opiates, Hypnotics

Disqualifiers: Pregnancy, Severe respiratory disorder, CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively adaptive servo ventilation (ASV) therapy improves sleep in individuals with moderate to severe insomnia. ASV therapy uses a specialized machine to regulate breathing during sleep. Participants should have a history of insomnia impacting daily life and should not have used other breathing-related sleep treatments. Those who frequently struggle with sleep and have not tried similar treatments may find this study suitable. As an unphased trial, it offers a unique opportunity to explore a new treatment option for enhancing sleep quality.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot start or stop sedative or psychotropic medications during the trial. If you wish to continue using sleeping pills or hypnotics, you cannot participate.

What prior data suggests that ASV Therapy is safe for treating insomnia?

Research has shown that ASV therapy is generally safe for people. In studies, patients using ASV therapy reported better sleep quality and fewer side effects compared to treatments like CPAP. One study found that ASV improved quality of life and reduced daytime sleepiness. These findings suggest ASV therapy is well-tolerated, with no major safety concerns reported. However, individual experiences can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ASV Therapy for insomnia because it offers a unique approach compared to current treatments like cognitive behavioral therapy, medications, or lifestyle changes. ASV, or Adaptive Servo-Ventilation, is a non-invasive ventilation therapy that adjusts air pressure automatically to stabilize breathing patterns during sleep. Unlike other treatments that primarily focus on altering sleep habits or affecting brain chemistry, ASV Therapy directly addresses potential breathing irregularities that can disrupt sleep, providing a novel solution for improving sleep quality. This innovative mechanism could offer relief for patients who have not responded well to traditional insomnia treatments.

What evidence suggests that ASV Therapy might be an effective treatment for insomnia?

Research has shown that ASV (adaptive servo ventilation) therapy, which participants in this trial will receive, can improve sleep quality. One study found that ASV worked better than CPAP (a common treatment for sleep apnea) in enhancing sleep. Another study demonstrated that people using ASV experienced better sleep in everyday life. Additional research found that ASV users spent more time asleep while in bed. These findings suggest that ASV therapy could help people with insomnia by enhancing their overall sleep quality. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with moderate to severe chronic insomnia. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I have not used any treatments for sleep-disordered breathing.

I am experiencing trouble sleeping.

I am 18 years old or older.

Exclusion Criteria

I have problems with breathing or feel very sleepy during the day.

I have been diagnosed with a severe respiratory or sleep disorder.

I do not have heart failure or severe sleep apnea that would prevent me from using PAP therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive servo ventilation therapy for insomnia

4 weeks

Follow-up

Participants are monitored for changes in insomnia severity and sleep onset latency after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASV Therapy

Trial Overview

The trial is testing the effectiveness of adaptive servo ventilation (ASV) therapy on reducing the severity of insomnia symptoms in affected individuals.

How Is the Trial Designed?

Group I: ASV Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

ResMed

Lead Sponsor

Trials

138

Recruited

47,600+

Mick Farrell

ResMed

Chief Executive Officer since 2013

Bachelor of Engineering from the University of New South Wales, Master of Science in Chemical Engineering from MIT, MBA from MIT Sloan School of Management

Dr. Carlos Nunez

ResMed

Chief Medical Officer since 2017

MD

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31517263/

CPAP & ASV for Chronic Complex Insomnia: Randomized Trial

Two sleep quality measures in the ANCOVA analysis again demonstrated superior significant effects for ASV compared to CPAP (both p < 0.03), and ...

2.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(24)05717-9/fulltext

Change in Sleep Quality Associated With Adaptive ...

In this study, individuals with a clinical indication for ASV therapy experienced improved sleep quality during real-world treatment, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0012369224057179

Change in Sleep Quality Associated With Adaptive ...

In this study, individuals with a clinical indication for ASV therapy experienced improved sleep quality during real-world treatment, regardless of which ASV ...

4.

publications.ersnet.org

publications.ersnet.org/content/erj/66/2/2500263

European Respiratory Society and European Sleep Research ...

Compared to control, ASV showed some improvement in sleep efficiency, sleep latency and RAI, mainly after 12 months of treatment, but ...

5.

atsjournals.org

atsjournals.org/doi/full/10.1513/AnnalsATS.202310-908OC

Effects of Adaptive Servo-Ventilation on Quality of Life

Conclusions: ASV treatment of CSA with or without coexisting OSA was associated with improvements in disease-specific QoL and daytime sleepiness ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6734001/

Prospective Randomized Controlled Trial on the Efficacy of ...

An advanced PAP mode—adaptive servo-ventilation (ASV)—may alleviate CPAP side-effects and yield superior outcomes ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07011966

Study Details | NCT07011966 | ASV Therapy for Insomnia

Adaptive servo ventilation (ASV) therapy using ResMed AirCurve 11 device will be used to target potential upper airway resistance and respiratory related ...