Study protocol for the Heads-Up trial: a phase II randomized controlled trial investigating head-up tilt sleeping to alleviate orthostatic intolerance in Parkinson's Disease and parkinsonism.

"Declarations Ethics approval and consent to participateThe study adheres to the principles of the Declaration of Helsinki and subsequent amendments, the Medical Research Involving Human Subjects act (WMO) and will be performed in accordance with Good Clinical Practice (GCP) guidelines with researchers certified on the principles of the Basic course on Regulations and Organization for clinical investigators (BROK® including ICH-GCP). Informed consent will be obtained from all the participants. They will only be allowed to participate after providing written informed consent, thereby agreeing that their anonymized data is used for analysis and shared after completion of the study. The study was approved by the METC Oost-Nederland ethics committee (NL80610.091.22) and is registered online at ClinicalTrials.gov (identifier NCT05551377). Currently in use is protocol version 13 (23 May 2023). All protocol modifications will be approved by the METC prior to implementation, and the trial registry will be updated accordingly. Consent for publicationNot applicable. Competing interestsAll authors declare that they have no competing interests. Below you can find the complete list of disclosures for BRB and RDT. BRB currently serves as Associate Editor for the Journal of Parkinson’s disease, has received honoraria from serving on the scientific advisory board for Zambon and Kyowa Kirin, has received fees for speaking at conferences from AbbVie, Zambon and Bial, and has received research support from the Netherlands Organization for Scientific Research (NWO), the Michael J Fox Foundation for Parkinson’s Research, UCB, the Stichting Parkinson Fonds, the Hersenstichting Nederland, the Parkinson’s Foundation, Verily Life Sciences, Topsector Life Sciences and Health, and the Parkinson Vereniging. RDT reports consultancy and speakers’ fees from Union Chimique Belge, Angellini, GlaxoSmithKline, Theravance, Novartis, and Zogenix; and grants from Medtronic. Competing interests All authors declare that they have no competing interests. Below you can find the complete list of disclosures for BRB and RDT. BRB currently serves as Associate Editor for the Journal of Parkinson’s disease, has received honoraria from serving on the scientific advisory board for Zambon and Kyowa Kirin, has received fees for speaking at conferences from AbbVie, Zambon and Bial, and has received research support from the Netherlands Organization for Scientific Research (NWO), the Michael J Fox Foundation for Parkinson’s Research, UCB, the Stichting Parkinson Fonds, the Hersenstichting Nederland, the Parkinson’s Foundation, Verily Life Sciences, Topsector Life Sciences and Health, and the Parkinson Vereniging. RDT reports consultancy and speakers’ fees from Union Chimique Belge, Angellini, GlaxoSmithKline, Theravance, Novartis, and Zogenix; and grants from Medtronic."

"Funding This study is funded by the Michael J. Fox Foundation for Parkinson’s research (Grand Central Station, P.O. Box 4777, New York, NY 10163 − 4777) (MJFF-020200). The center of expertise for Parkinson and movement disorders is supported by a center of excellence grant by the Parkinson Foundation. The sponsor is not involved in performing any part of the study, nor did the sponsor influence the study protocol. In accordance with the sponsor the results of this RCT will be published open access. The study has also received a donation from the Nico Job Bije stichting for the development of study materials."

"Trial registration ClinicalTrials.gov NCT05551377; Date of registration: September 22, 2022."