Heated Blanket + CBT-I for Insomnia
(SLEEPS2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test whether combining digital Cognitive Behavioral Therapy for Insomnia (CBT-I) with sessions using a heated sauna blanket improves sleep for people with insomnia. All participants will receive CBT-I, but only some will also use the heated blanket. The study targets adults who have trouble falling asleep and can access the internet daily. Participants should not work night shifts or regularly use hot tubs or saunas before bed. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for insomnia.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are using medications for mental health treatment, you must have been on a stable dose for the prior 8 weeks.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that passive body heating (PBH) is generally safe. PBH uses a sauna blanket to gently warm the skin, helping people fall asleep faster and improving sleep quality. No major reports of harmful side effects from PBH have emerged.
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a well-known treatment for insomnia that helps change sleep habits and thoughts. Many have used CBT-I safely, and its safety is supported by its widespread use.
Overall, both PBH and CBT-I have demonstrated safety for people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for insomnia because they combine Cognitive Behavioral Therapy for Insomnia (CBT-I) with innovative approaches. The experimental treatment adds Passive Body Heating (PBH) using a sauna blanket to the mix, which is a unique feature not seen in standard care. This combination may enhance relaxation and improve sleep quality more effectively than CBT-I alone. By integrating digital delivery of CBT-I, the treatments also offer greater accessibility and convenience for participants, potentially reaching a wider audience struggling with insomnia.
What evidence suggests that this trial's treatments could be effective for insomnia?
Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively improves sleep problems. It is considered the best treatment because it consistently enhances sleep quality. In this trial, some participants will receive CBT-I alone. Research has also shown that Passive Body Heating (PBH), such as using a sauna blanket, can help individuals fall asleep faster and improve overall sleep quality. PBH works by warming the skin, which helps the body relax and prepare for sleep. Other participants in this trial will receive a combination of CBT-I and PBH, potentially offering a robust approach to tackling insomnia by addressing both the mental and physical aspects of sleep.12467
Who Is on the Research Team?
Ashley E Mason, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Adults aged 18 or older with insomnia disorder are eligible for this study. The trial is designed to help those struggling with sleep issues and possibly related mood disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket over a 9-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Passive Body Heating (PBH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator