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The HEADS-Up Trial: Sleeping in a head-up tilt position to treat orthostatic hypotension, supine hypertension and nocturia in Parkinson's disease

The HEADS-Up Trial: Sleeping in a head-up tilt position to treat orthostatic hypotension, supine hypertension and nocturia in Parkinson's disease - HEADs UP

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51733
Enrollment
50
Registered
2022-07-07
Start date
2023-01-18
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Parkinson's disease

Interventions

All participants will sleep in whole-body head-up tilt (HUTS) in three angles for two weeks (6°, 12° and 18° for the intervention group
1°, 6° and 12° for control groups). The 1° condition in the control group is considered the control intervention. and each angle is preceded by a week ofof the HUTS sleeping position is The interve

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. 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 = 30 mmHg is required. 2. Orthostatic intolerance: direct complants (dizziness, tunnel- or blurry vision etc.) and/or inirect signs (falls or freezing episodes that relate to postual challenge) 3. Supine hypertension defined as a systolic BP of >=140 mmHg, and/or diastolic of >=90 mmHg, after 5 min of supine rest. 4. Idiopathic PD. 5. Ability to walk (with or without a walking aid). 6. Stable medication regimens for orthostatic hypotension and supine hypertension.

Exclusion criteria

Exclusion criteria: Cognitively unable to follow instructions or to fill out questionnaires as judged by the researcher

Design outcomes

Primary

MeasureTime frame
Overnight blood pressure (BP) from 24-hour ABPM between patients and controls

Secondary

MeasureTime frame
Secondary endpoints include: daily supine blood pressure, orthostatic blood pressure, orthostatic tolerance (complaints of orthostatic hypotension), nocturia, PD motor- and non-motor symptoms, physical activity during the day, falls and subjective comfort of HUTS.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)