Smartphone CBT‑I app for insomnia in cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize 146 Canadian adult cancer survivors meeting DSM‑5 criteria for insomnia to immediate access to a seven‑module CBT‑I app (iCANSleep) or to an 8‑week waitlist with delayed access. The immediate group completes the modules right away while the delayed group begins after the wait period; both groups complete assessments at baseline, mid‑treatment, post‑treatment, and at 3‑month follow‑up (the delayed group has extra assessments during the wait). The primary outcome is change in Insomnia Severity Index (ISI); secondary measures include fatigue, anxiety, depression, pain, work productivity, sleep beliefs, daytime impact, and pre‑sleep arousal. Eligibility requires adults living in Canada who are fluent in English or French, own a smartphone with internet access, and meet performance and stability/remission criteria to ensure insomnia is not an acute response to treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cancer survivors
* Over 18 years of age
* Lives in Canada
* Understands English or French fluently
* DSM-5 diagnosis of insomnia
* ISI score of 8 or higher
* Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
* Access to internet connection
* Ownership of smartphone
* Fluency using mobile applications.
* Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollment (for individuals with non-metastatic cancer) or be on a stable treatment regimen for the prior 3 months (for individuals with metastatic cancer) to ensure that insomnia is not a direct, acute response to cancer treatment.
* Individuals with hematological malignancies must be in remission at the time of recruitment and have completed cancer treatments (e.g., transplant, chemotherapy, immunotherapy, radiotherapy) at least 3 months prior.

Exclusion Criteria:

* Presence of a sleep disorder other than insomnia that is not adequately treated (e.g., untreated sleep apnea)
* Presence of a psychological disorder that is currently untreated or would impair the ability to participate (e.g., bipolar disorder)
* Major sensory deficit (e.g., blindness)
* Previous experience receiving CBT-I.
* The use of medications prescribed for sleep (e.g., hypnotics, sedatives, or antidepressants) will be tracked and adjusted for in the statistical analysis.

Where it's running

• Memorial University of Newfoundland
  St. John's, Newfoundland and Labrador, Canada Recruiting

Study contacts

• Principal investigator: Sheila N Garland — Memorial University of Newfoundland
• Study coordinator: Sheila N Garland
• Email: icansleepapp@gmail.com
• Phone: 1 (709) 864-8035

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SleepCogni for children with chronic insomnia

  A handheld SleepCogni device is tested to see if it helps kids aged 6–16 with chronic insomnia sleep better.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield · NCT07926724

• Music therapy after stroke

  This trial tests whether adding music therapy to standard care helps stroke patients sleep better and feel less anxious or depressed while in the hospital.

  Recruiting Universidad de Granada · Granada, Granada · NCT07899034

• Remote ischemic conditioning for post-stroke insomnia

  A 136-person, randomized study will test whether a non-invasive arm-cuff procedure done twice daily for 90 days can improve sleep after a first ischemic stroke in adults 18–80.

  Recruiting Sichuan Academy of Medical Sciences · Chengdu, Sichuan · NCT07874594

• Nurse-guided app-based brief behavioral therapy for insomnia in older adults

  Aging adults with insomnia will be asked to try a nurse-supported, smartphone app therapy for four weeks to see if it helps with sleep.

  Recruiting Taipei Medical University · Taipei · NCT07842250

• Three rTMS approaches to lessen insomnia-related pain after exercise-induced muscle soreness

  This study tests whether three different rTMS approaches can reduce pain sensitivity and improve recovery in adults with insomnia after inducing muscle soreness from exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07827677

• Insomnia and Sleep Disruption's Effect on Pain Sensitivity and Muscle Soreness After Exercise

  This study tests whether poor sleep or insomnia affects how people feel pain and recover from exercise-induced muscle soreness in healthy adults.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07827664

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.