Boston, MANCT06972303Now EnrollingIRB Ready

Sleep Initiation and Maintenance Disorders Clinical Trial in Boston, MA

Access cutting-edge sleep initiation and maintenance disorders treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Brigham and Women's Hospital

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Expert Care in Boston

Access sleep initiation and maintenance disorders specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related sleep initiation and maintenance disorders treatment provided free

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Check if you qualify for this sleep initiation and maintenance disorders clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Sleep Initiation and Maintenance Disorders Study in Boston

The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion Criteria

Age 18 years and older;
Chronic insomnia (≥ 3 nights/week, for ≥ 3 months), defined by DSM-V or ICSD-3;
Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency \>20 min;
Insomnia Severity Index score ≥ 15;
Speak and understand English;
Have a smart device (phone or tablet) for mobile app installation

Exclusion Criteria

Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);
Shift worker or routine night shifts;
Women with pregnancy or breastfeeding;
Regular (defined as twice a week or more) practice of mind-body interventions;
Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);
Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;
Currently under medications with sleep changing effects (e.g., anxiolytics/benzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);
Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06972303) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Sleep Initiation and Maintenance Disorders Treatment Options in Boston, MA

If you're searching for sleep initiation and maintenance disorders treatment options in Boston, MA, this clinical trial (NCT06972303) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced sleep initiation and maintenance disorders specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all sleep initiation and maintenance disorders clinical trials near you to find additional studies recruiting in your area.

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