Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are female and aged 18 or older
• People who have been diagnosed with a specific type of early-stage breast cancer (called Ductal Carcinoma In Situ or stage I–III invasive breast cancer), confirmed through a tissue sample test
• People whose general physical functioning falls within a certain range, meaning they are able to carry out everyday activities with no more than moderate limitation (confirm with trial site)
• People with a body mass index (BMI) of 25 or higher and a body weight of 400 pounds or less
• People who are willing to work toward losing 10% of their body weight
• People whose breast cancer diagnosis was made within the last 10 years
• People who have finished surgery, radiation, and any planned chemotherapy, immunotherapy, or targeted therapy at least 3 months before joining — ongoing hormone therapy is allowed
• People who have completed all planned surgeries at least 4 weeks before joining
• People who meet the clinical definition of Insomnia Disorder based on a standard psychiatric checklist (DSM-5)
• People who report taking more than 30 minutes to fall asleep or waking for more than 30 minutes during the night, on more than 3 nights per week
• People who have had sleep problems for 3 months or longer
• People who score 9 or higher on a standard insomnia severity questionnaire

Who may not be able to join:

• People with a serious or uncontrolled medical or psychiatric condition (such as bipolar disorder, psychotic disorder, seizure disorder, or autoimmune disease) that could interfere with participation
• People currently taking medications that are known to disturb sleep or affect body weight, including sleeping tablets or sedatives
• People who have a sleep disorder other than insomnia — although mild sleep apnea, or moderate-to-severe sleep apnea that is being successfully treated with an airway pressure device (PAP therapy), may be permitted
• People currently enrolled in, or planning to join, a separate sleep treatment or weight loss program during the study period
• People whose overnight sleep breathing test shows an apnea/hypopnea index (a measure of breathing interruptions during sleep) greater than 15 (confirm with trial site)
• People with a history of an unstable psychiatric disorder
• People who report thoughts of suicide, or who show severe depressive symptoms as assessed by a clinical interview — including a score of 20 or higher on a standard depression questionnaire
• People who are pregnant, breastfeeding, or planning to become pregnant in the next 14 months
• People whose urine test is positive for recreational drugs, or who have an alcohol or substance use disorder as identified through standard clinical interviews
• People who smoke or use nicotine products daily
• People who, in the opinion of the trial investigators, may be at increased risk or are unlikely to be able to fully complete the study

Important: Always verify eligibility with the trial site directly before applying.