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.

ABSTRACT:

Background

In persons with Parkinson's Disease (PD) or certain forms of atypical parkinsonism, orthostatic hypotension is common and disabling, yet often underrecognized and undertreated. About half of affected individuals also exhibit supine hypertension. This common co-occurrence of both orthostatic hypotension and supine hypertension complicates pharmacological treatments as the treatment of the one can aggravate the other. Whole-body head-up tilt sleeping (HUTS) is the only known intervention that may improve both. Evidence on its effectiveness and tolerability is, however, lacking, and little is known about the implementability.

Methods

In this double-blind multicenter randomized controlled trial (phase II) we will test the efficacy and tolerability of HUTS at different

SUBMITTER: van der Stam AH 

PROVIDER: S-EPMC10759619 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature