60 Participants NeededMy employer runs this trial

Acoustic Resonance vs Cognitive Behavioral Therapy for Insomnia

SL
SC
Overseen ByShawn C Fokken, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Sleep-aiding pills
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare changes in sleep quality in patients with moderate to severe insomnia, in participants randomized to Cognitive Behavioral Therapy for Insomnia (CBT-I) arm versus those randomized to the SONU Headband Acoustic Resonance Therapy (ART) arm at end of treatment (6 weeks).

Who Is on the Research Team?

RH

Ryan Hurt, MD, PhD

Principal Investigator

Mayo Clinic

IT

Ivana T Croghan, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

* Not pregnant by subject self-report at time of consent.
* Have the ability to provide informed consent.
I am able to follow all trial instructions and attend required visits.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either Acoustic Resonance Therapy (ART) using a wearable headband or Cognitive Behavioral Therapy for Insomnia (CBT-I) through interactive modules for 6 weeks

6 weeks

Follow-up

Participants are monitored for changes in sleep quality and impairment after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acoustic Resonance Therapy (ART)
  • Mayo Clinic Cognitive Behavioral Therapy for Insomnia (CBT-I)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: A wearable headband (SONU)Experimental Treatment1 Intervention
Group II: Interactive Modules delivering cognitive behavioral therapy for insomniaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+