ASV Therapy for Insomnia
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.12345
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.23567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adaptive servo ventilation therapy for insomnia
Follow-up
Participants are monitored for changes in insomnia severity and sleep onset latency after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASV Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
ResMed
Lead Sponsor
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