Application of limited channel home sleep studies in children.

Limited channel sleep studies (L3 studies) will be undertaken in the home, in addition to the clinically-indicated laboratory-based (L1 PSG) sleep study which is undertaken in the hospital environment. The L3 study will occur ahead of, and within 4 weeks of the L1 PSG. The focus of this project, is to determine the appropriate balance between the relative ease of use for L3 (home) studies and detailed evaluation of how effective they are for assessment of respiratory sleep disorders in children. We will study a broad population of children referred for evaluation and treatment of respiratory sleep disorders. The project will be conducted in two stages: • Phase 1: Collaboration with consumers to co-design specifics of the conduct of level 3 studies. These studies can be set up by sleep scientists or parents in the hospital or a child’s home. Focus groups will be facilitated by an experienced qualitative researcher. Six to eight parents of children who have undergone L1 (laboratory) PSG will be invited to participate in two, online, 1-hour focus groups held over the course of a month. The focus groups will include a sleep scientist who can answer questions on the study processes and the different options being offered. Families will be offered the option of trialling an L3 home study with their child, and they will be asked to evaluate and provide feedback on their order of preference for the different methods of delivering the L3 (home) studies. Options include A group of six to eight sleep scientists will be involved in a separate focus group meeting to evaluate their experience of, and preferences for the L3 home sleep study delivery. A final focus group will include parents and sleep scientists to determine a consensus between families and sleep scientists on the best method for setting up and delivering the L3 home studies. • Phase 2a:will commence approximately 6 months later. Limited channel (L3) sleep studies will be offered to all children on waiting lists for L1 PSG, using the consensus method determined in Phase 1. The home (L3) study will be conducted for a single night, within one month prior to the child’s scheduled L1 PSG (with an option for repeating the study on a second night if the first attempt fails). Clinical management will follow the clinicians recommendation after they review the L1 PSG. Primary analysis will compare the accuracy of the L3 (limited channel home) study for evaluating sleep disordered breathing in children, compared to the standard laboratory-based L1 PSG. The study goal is to determine the diagnostic accuracy of home L3 studies compared to L1 PSG, and to obtain feedback from families on their experience with each form of monitoring using both qualitative and quantitative methods. No specific device has been selected for trial, with any device suitable providing it can record the necessary channels by recording: - Airflow - oxygen saturation (oxygen saturation monitor) - respiratory effort (most commonly plethysmography bands) - ECG/ heart rate The study outcomes will be analysed independently of the clinical L1 PSG. Clinicians blinded to the alternative study will make treatment or intervention recommendations on the basis of both the L1 PSG and the L3 studies. The primary study outcome will be comparison of the clinician-recommended treatment or intervention made on the basis of the L3 study compared to the clinician-recommended treatment or intervention made on the basis of the L1 PSG. Phase 2b: The final phase will be an economic evaluation of home L3 studies in comparison to L1 PSG. by collecting relevant healthcare costs associated with children on waiting lists for L1 PSG with relevant cost analyses. This requires that participating families complete relevant questionnaires and consent to collection of health utilisation data for their child.