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Study Objectives Sleep problems are common during chemotherapy for breast cancer (BC). We evaluated whether combined brief cognitive behavioral and bright light therapy (CBT-I+Light) is superior to treatment as usual with relaxation audio (TAU+) for insomnia symptoms and sleep efficiency (primary outcomes). Methods We randomized women receiving intravenous chemotherapy, stratified by tumor stage and insomnia severity index (ISI), to 6-weeks CBT-I+Light or TAU+. CBT-I+Light included one in-person session, one telephone call, seven emails, and 20 minutes bright light each morning. TAU+ comprised usual treatment and two emails with relaxation audio tracks. Patient-reported outcomes were assessed at baseline, midpoint (week 3), post (week 6) and 3-month follow-up. Results Women (N = 101) were randomly assigned to CBT-I+Light or TAU+. The CBT-I+Light group showed significantly greater improvement in insomnia symptoms than the TAU+ group (-5.06 vs -1.93, P = .009; between-group effect size [ES] = .69). At 3-month follow-up, both groups were lower than baseline but did not differ from each other (between-group ES = .18, P = .56). CBT-I+Light had higher patient-reported sleep efficiency than TAU+ immediately after the start of intervention (P = .05) and significantly greater improvement in fatigue (between-group ES = .59, P = .013) and daytime sleep-related impairment (between-group ES = .61, P = .009) than the TAU+ group. Conclusion CBT-I+Light had a clinically significant impact on insomnia and fatigue with moderate effect sizes. Results support offering cognitive behavioral therapy for insomnia and bright light therapy during chemotherapy for breast cancer to help manage sleep and fatigue.

Background: Women with breast cancer experience a significantly higher prevalence of sleep disturbance and insomnia than the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment for sleep in this population is not part of routine care and is often managed inadequately. This randomised controlled trial will examine the combined effects of cognitive behavioural therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue and mental health. Method/design: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne, Australia, will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio-enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBTbased information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 min each morning for the 6-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT, and sleeprelated complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). Data will also be collected on potential treatment moderators and mechanisms and adherence to treatment. There will be 3-month follow-up measurements of insomnia symptoms, fatigue, sleeprelated impairment, sleep disturbance, depression and anxiety.

Purpose: Obstructive sleep apnea (OSA) is less prevalent among women and is associated with different symptoms and consequences to OSA in men. The reasons for these differences are unknown and difficult to tease apart in clinical populations. If OSA could be temporarily induced in healthy men and women, the causes of some of these differences could be investigated. Nasal blocking has been used to induce OSA in healthy men but its effect in women has not been reported. Patients and Methods: A total of 14 healthy individuals (10 women) underwent inlaboratory diagnostic sleep studies on two occasions separated by a week. On one occasion, the nasal passages were blocked, whereas on the other occasion, participants slept naturally. In both conditions, a full-face mask was used to monitor respiratory events. Participants' self-reported sleepiness, mood and performance on a motor learning task were assessed in the evening and morning of both sleep studies. Furthermore, endothelial function and selfreported sleep quality were assessed in the morning following each study. Results: Nasal blockage induced OSA in healthy young (age=22±3 years) and slim (BMI=22.2 ±3.2 kg/m 2) women (control AHI=2.0±2.6, blocked AHI=33.1±36.7 events/hr, p=0.02). One night of OSAwas associated with poorer self-reported sleep quality (p<0.001) and increased self-reported snoring (p<0.04), choking and gasping during sleep (p<0.001) but was not associated with alterations in mood, neurocognitive or endothelial function on the following morning. Conclusion: Nasal blockage induces OSA in healthy, young, and normal weight women. However, whether the induced OSA is representative of naturally occurring OSA and the technique useful for future studies is unclear.