Comparing Acoustic Resonance Therapy (ART) vs. Cognitive Behavioral Therapy for Insomnia (CBT-I)
A legfontosabb adatok
- Hol
- Rochester (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Mayo Clinic in RochesterRochester, Egyesült ÁllamokContact: Stephanie Lindeen, RNRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Mayo Clinic
- Azonosító
- NCT07486882
- A regiszteradat frissítve
- 2026. július 20.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
A Feasibility Pilot Comparing Acoustic Resonance Therapy (ART) to Cognitive Behavioral Therapy for Insomnia (CBT-I) for Treating Patients With Moderate to Severe Chronic Insomnia Disorder
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).
Bevonási feltételek: Adult subjects, 22 years of age and older at screening; Moderate-to-severe insomnia disorder, as defined by the International Classification of Sleep Disorders (ICSD-3)* and the Insomnia Severity Index (ISI) and have been diagnosed for more than three months; Not pregnant by subject self-report at time of consent; Have the ability to provide informed consent; Have the ability to complete all aspects of this trial; Have access to an iOS mobile device (iPhone X or above); Have no contraindicating comorbid health condition that would interfere with the proper use of the SONU Headband system, as determined by the clinical investigators; Participants who are taking sleep-aiding pills must agree to no changes to medication and dosage during the study; According to the third edition of the International Classification of Sleep Disorders (ICSD-3), insomnia is characterized by difficulty in either initiating sleep, maintaining sleep continuity, or poor sleep quality.
Kizáró feltételek: Patients who have a clinically significant or unstable medical or surgical condition; Participants using pacemakers or cardiac monitors; Participants with severe physical illness or immediately post-surgery; Participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder, or severe neurological diseases such as a seizure, stroke, or Parkinson's disease; Participants with other serious sleep disorders, such as severe obstructive sleep apnea; Any unstable medical or mental health condition as determined by the physician investigator; Patients who are unable to commit to avoiding the consumption of alcohol during the study; Patients who are unable to commit to avoid consumption of caffeine after 12 pm (noon); Participants who are unable to attend regular follow-up evaluations.