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Funded Studies

The Heads-Up Trial: Exploring the Effects of Sleeping in a Head-up Tilt Position on Blood Pressure in Parkinson’s Disease

Study Rationale: Parkinson’s disease (PD) affects the function of the autonomic nervous system, which controls blood pressure (BP), often resulting in both a low BP upon rising (orthostatic hypotension, a cause of fainting or falls) and a concerningly high BP while lying flat (supine hypertension). This common co-occurrence complicates treatment, as improvement of one can only be accomplished at the expense of the other. Sleeping in a head-up tilt position (HUTS) is an attractive noninvasive, nonpharmacological intervention with the unique ability to treat both conditions simultaneously. However, HUTS has never been tested in adequately designed studies.

Hypothesis: In evaluating the optimal tilt angle for HUTS, we hypothesize that there will be a trade-off between efficacy and tolerability, with larger tilt angles shown to be more effective, but less tolerable. We will also assess whether certain baseline features, like orthostatic hypotension severity, can predict a successful treatment outcome.

Study Design: The Heads-up trial is a double-blind, home-based randomized control trial (RCT) that will provide robust data on the efficacy and tolerability of HUTS. Fifty participants will be randomized to either the intervention or control group. All will undergo HUTS for two weeks, with those in the intervention group testing three angles presumed to be effective and the control group a placebo 1° tilt. Each HUTS treatment will be preceded by one week sleeping horizontally, so the total trial duration will be 9 weeks. Home-based assessments include daily BP monitoring, a continuous activity tracker and weekly questionnaires on a phone app.

Impact on Diagnosis/Treatment of Parkinson’s Disease: If proven effective, HUTS implementation may significantly reduce incapacitating orthostatic hypotension and hypertensive emergencies in PD, as well as long-term organ failure due to supine hypertension (e.g. myocardial infarction, stroke). To optimize clinical implementation, we will develop a video animation to explain the rationale of HUTS.

Next Steps for Development: If the present study is successful, we will use the results to design a definitive phase 3 RCT, powered to study clinically relevant outcomes. Ultimately, we our results could provide a roadmap for treating orthostatic hypotension and supine hypertension in PD.


Researchers

  • Roland D. Thijs, MD, PhD

    Leiden Netherlands


  • Bastiaan R. Bloem, MD, PhD

    Nijmegen Netherlands


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