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

Last updated: May 8, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Parkinson's Disease

Treatment

Head-up tilt sleeping

Clinical Study ID

NCT05551377
NL.80610.091.22
MJFF-020200
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Orthostatic hypotension defined as a systolic BP decrease of ≥20 mmHg, or a diastolicdecrease of ≥10 mmHg, within 3 min after changing from a supine to standing positionOR mean standing BP of ≤75 mmHg (marker for symptomatic orthostatic hypotension). Inpatients with supine hypertension, a decrease in systolic BP of ≥ 30 mmHg is required;
  • Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/orindirect signs (falls or freezing episodes that relate to postural challenge);
  • Supine hypertension defined as a systolic BP of ≥140 mmHg, and/or diastolic of ≥90mmHg, after 5 min of supine rest;
  • Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclearpalsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia);
  • Ability to walk (with or without a walking aid), as subjectively determined by theresearcher;
  • Stable medication regimens for orthostatic hypotension and supine hypertension duringthe trial;

Exclusion

Exclusion Criteria:

  • Inability to follow instructions and complete questionnaires, as assessed by theresearcher;

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Head-up tilt sleeping
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
June 30, 2024

Study Description

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.

Connect with a study center

  • Radboudumc

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, Zuid Holland 2333 ZA
    Netherlands

    Site Not Available

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