Investigator/Author: Roland Thijs, Leiden University Medical Center
Objective: Autonomic dysfunction is common, disabling and often underrecognized in Parkinson’s disease (PD). Orthostatic hypotension (OH) affects up to a third of patients with PD. About half of them also exhibit supine hypertension (SHT). In current clinical practice, both OH and SHT are undertreated. Importantly, the common co-occurrence of OH and SHT complicates pharmacological treatment, as improvement of one can be accomplished only at the expense of the other. The Heads-Up trial aims to evaluate a well-known, straightforward but understudied and widely underutilized intervention for autonomic dysfunction in PD: sleeping in head-up tilt (SHU).
Background: The concept of SHU is based on clinical observations made 70 years ago. Based on several small-scale studies and expert opinion, SHU has been proposed as a first-choice treatment for OH for over three decades, but it is often not advised to patients in daily practice. Moreover, when it is recommended, most physicians prescribe low tilt angles which have no effect on symptoms. The aim of this study is to provide a robust evidence base for SHU, by studying the feasibility and efficacy of SHU and optimizing the conditions for best treatment effects.
Methods/Design: 60 PD patients with OH will be tested in a well-designed randomized controlled trial. The primary aim is to determine the optimal angle of SHU. The trial will adopt a unique personalized approach with angles adjusted to OH severity. The hypothesis is that SHU will improve SHT and OH (primary aim), and thereby have a positive effect on clinically relevant outcomes, including motor symptoms, nycturia, sleep quality and number of syncopal falls (secondary aim). In addition, the project will create an animation for patients, explaining the underlying mechanisms, and develop a practice guideline of SHU for PD-OH.
Relevance to Diagnosis/Treatment of Parkinson’s Disease: This project addresses an unmet need for PD patients by testing a nonpharmacological intervention for troubling yet difficult to treat symptoms. If the intervention proves feasible and effective, the plan is to conduct a definitive phase 3 randomized controlled trial, informed by the crucial preparatory work proposed here. Ultimately, this could lead to changes in standard of care and improve the quality of life for PD patients.