Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease

Radboud University Medical Center50 enrolled

Overview

Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.

Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Orthostatic hypotension defined as a systolic BP decrease of ≥20 mmHg, or a diastolic decrease of ≥10 mmHg, within 3 min after changing from a supine to standing position OR mean standing BP of ≤75 mmHg (marker for symptomatic orthostatic hypotension). In patients with supine hypertension, a decrease in systolic BP of ≥ 30 mmHg is required; * Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge); * Supine hypertension defined as a systolic BP of ≥140 mmHg, and/or diastolic of ≥90 mmHg, after 5 min of supine rest; * Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia); * Ability to walk (with or without a walking aid), as subjectively determined by the researcher; * Stable medication regimens for orthostatic hypotension and supine hypertension during the trial; Exclusion Criteria: * Inability to follow instructions and complete questionnaires, as assessed by the researcher;

Outcomes

Primary Outcomes

Average overnight supine blood pressure

Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)

Time frame: Measured four times: in week 1, 3, 5 and 7

Secondary Outcomes

Daily supine blood pressure

Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed

Time frame: Daily in week 1 up to and including week 7

Orthostatic blood pressure

Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.

Time frame: Measured six times: in-clinic (T0; pre-intervention), in week 1, 3, 5 and 7, and in-clinic on the day after week 7 ends (T1; post-intervention)

24h ABPM parameters

24h ABPM parameters blood pressure variability (mmHg), nocturnal blood pressure dipping (mmHg) and average daytime blood pressure (mmHg). Each of these measures will be derived from the 24 hour blood pressure measurements, and reported separately.

Time frame: In week 1, 3, 5 and 7

Orthostatic tolerance

Self-reported burden of symptoms of orthostatic hypotension (Orthostatic hypotension questionnaire (OHQ)). The score ranges from 0 to 100, with a higher number meaning worse symptoms of orthostatic hypotension.