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

NCT05551377 | Unknown DMC

• 2 other identifiers: NL.80610.091.22MJFF-020200
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Parkinson Disease; Parkinsonism

Keywords

Parkinson's disease; Orthostatic hypotension; Supine hypertension; Autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• Average overnight supine blood pressure

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

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

Secondary Outcomes (10)

• Daily supine blood pressure

  Daily in week 1 up to and including week 7

• Orthostatic blood pressure

  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

  In week 1, 3, 5 and 7

• Orthostatic tolerance

  Week 1, 3, 5 and 7

• Nocturia

  Week 1, 3, 5 and 7

Other Outcomes (9)

• Timed up and go test (TUG)

  Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)

• Symptoms of Parkinson's disease

  Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)

• Quality of sleep

  Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)

Study Arms (2)

Intervention group

EXPERIMENTAL

At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls.

Other: Head-up tilt sleeping

Delayed intervention group

OTHER

Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention.

Other: Head-up tilt sleeping

Interventions

Head-up tilt sleeping OTHER

Whole-body head-up tilt sleeping (HUTS) will be carried out in three different angles, each for the duration of two weeks. Prior to the first angle the participant will sleep in a horizontal position for 1 week. The different angles will be installed using a wedge between the mattress and bed frame.

Delayed intervention group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Leiden University Medical Center: collaborator
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• van der Stam AH, de Vries NM, Shmuely S, Smeenk D, Rutten JH, van Rossum IA, de Bot ST, Claassen JA, Bloem BR, Thijs RD. 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. BMC Neurol. 2024 Jan 2;24(1):4. doi: 10.1186/s12883-023-03506-x.

  PMID: 38166676 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Hypotension, Orthostatic; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Orthostatic Intolerance; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Roland D Thijs, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the investigator and the participants are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are divided into two groups, the intervention and control (delayed intervention) group.

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: January 18, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Study protocol and statistical analysis plan are shared with the funding foundation prior to the onset of the study. After completion of the measurements and analysis we will share the clinical study report with the funding foundation and place relevant and anonymized data on the DANS Easy database.
• Access Criteria: Access to the data is restricted, meaning that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.

Locations

NL (2)