# M4 Sleep-EDF Primary-Horizon Pre-Analysis Plan This note documents the committed M4 Sleep-EDF execution contract. It is a prospective pre-analysis plan for a future local/public-data run, not a completed Sleep-EDF result. ## Scope - Dataset: PhysioNet Sleep-EDF Expanded. - Raw data policy: raw PSG and hypnogram files must stay outside the repository. - Split/cluster unit: dataset-scoped Sleep-EDF subject ID parsed from the filename. - Session boundary unit: subject/night ID parsed from the filename. - Primary horizon: horizon 1. - Descriptive horizons: horizons 2 and 3. - Primary endpoint: RFS bits versus the strongest gated nuisance/trivial baseline. - Claim boundary: benchmark-method hardening only. This does not permit clinical, diagnostic, treatment, or model-superiority claims. ## Required Gates The primary horizon is the only inferential horizon in this protocol. Other horizons are descriptive unless a separate multiplicity-controlled plan is added. The future Sleep-EDF execution must fail closed if: - the local Sleep-EDF root is inside the repository, - Sleep-EDF filenames cannot be parsed into subject and night metadata, - primary-horizon event patients are below 8, - primary-horizon positive events are below 100, - the primary RFS confidence interval includes zero, - shuffled-target or time-shift controls are too close to primary RFS, - the patient-cluster sign-flip permutation is not significant, - any nuisance probe exceeds chance plus 0.20. ## Provenance Requirements The runner writes redacted execution metadata only. It records file names, file hashes, parsed subject IDs, parsed night/session IDs, pair counts, the preregistration hash, the primary-horizon result, and gate failures. It does not record absolute local raw-data paths. ## Sources - PhysioNet Sleep-EDF Expanded v1.0.0 documents the public PSG/hypnogram dataset, EDF format, and manual sleep-stage scoring. - EEG leakage literature motivates subject/session-aware splits and fail-closed nuisance probes because segment-level random splits can overestimate performance. - Human medical intervention evidence, such as randomized-trial meta-analysis of exercise for depression, is relevant only to treatment claims. This M4 feature makes no intervention, depression, clinical, or treatment claim.