NCT05816460

The Sleepio After Cancer Study

The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.

Detailed description

Women who are eligible and provide informed consent will be enrolled into this 2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm). The primary outcome will be the mean continuous change in sleep condition indicator (SCI) score in the intervention arm compared to the control arm at 6 months. In addition to this, the proportion of women with an SCI \> 16 at 6 months will be assessed. Secondary outcomes will include fatigue, sleep related quality of life, depression, anxiety, as well as hot flush interference in those experiencing vasomotor symptoms.

Conditions

• Insomnia
• Cancer

Interventions

Type	Name	Description
OTHER	Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)	Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an online platform called Sleepio (BigHealth Ltd)
OTHER	Sleep Hygiene Education (SHE)	Sleep Hygiene Education (SHE) will be provided electronically

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2023-04-18
• Last updated: 2023-05-23

Locations

1 site across 1 country: Ireland