Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06938802
Eligibility Criteria:
Cancer Survivor eligibility criteria:
Inclusion Criteria:
1. Diagnosed with any cancer,
2. Completed curative treatment six months to five years before enrolling (excepting ongoing adjuvant endocrine therapy),
3. Score 8 to 14 on the Insomnia Severity Index (ISI)
4. Have a consistent bedroom partner (i.e., sleep in the same bedroom 4 or more nights per week).
Bedroom partner eligibility criteria:
1\) No cancer within the past five years
Both survivors and bedroom partners:
Inclusion:
1. Age \> or =18 years,
2. Able to speak and read English,
3. Able to provide informed consent,
Exclusion:
4. No changes in type or dose of prescription sleep medications in the past three months,
5. Not engaged in behavioral sleep treatment for six months prior to enrollment,
6. Not planning to travel across 3 time zones or more during the eight intervention weeks or for the two weeks leading up to study assessments,
7. Not pregnant at enrollment or planning to become pregnant during the study,
8. No diagnosed or suspected psychiatric or medical condition that could interfere with participation,
9. No commitments that would interfere with regular night time sleep patterns (e.g., shift work),
10. No known untreated non-insomnia sleep disorders (e.g., sleep apnea, restless legs syndrome, hypersomnia, circadian rhythm sleep-wake disorder).
Enrolled participants will be allowed to remain in the study even if the other member of their dyad withdraws.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06938802
Study Brief:
Protocol Section:
NCT06938802