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

May 8, 2024 updated by: Radboud University Medical Center

The Heads-Up Trial: Sleeping in a Head-Up Tilt Position to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboudumc
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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
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.
Other: Delayed intervention group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average overnight supine blood pressure
Time Frame: Measured four times: in week 1, 3, 5 and 7
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily supine blood pressure
Time Frame: Daily in week 1 up to and including week 7
Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed
Daily in week 1 up to and including week 7
Orthostatic blood pressure
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)
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
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
Time Frame: In week 1, 3, 5 and 7
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.
In week 1, 3, 5 and 7
Orthostatic tolerance
Time Frame: Week 1, 3, 5 and 7
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.
Week 1, 3, 5 and 7
Nocturia
Time Frame: Week 1, 3, 5 and 7
Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N))
Week 1, 3, 5 and 7
Subjective comfort of HUTS (head up tilted sleeping)
Time Frame: Week 1, 3, 5 and 7
Self-reported tolerability of the head up tilted sleeping at different angles including questions about sleep duration, sleep quality and comfort, and feeling rested in the morning.
Week 1, 3, 5 and 7
Falls
Time Frame: Week 1, 3, 5 and 7
Self-reported falls and in case of a fall additional questions about the time and circumstances
Week 1, 3, 5 and 7
Overnight change in body weight
Time Frame: Daily in week 1 up to and including week 7
Weight (kg) difference between the evening and the morning, both measured after micturition
Daily in week 1 up to and including week 7
Nighttime urine production
Time Frame: Week 1, 3, 5 and 7
Urine volume measured in a urinal (ml)
Week 1, 3, 5 and 7
Barriers and facilitators of the intervention
Time Frame: Immediately post-intervention (day after week 7, T1)
Structured interview
Immediately post-intervention (day after week 7, T1)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed up and go test (TUG)
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Measurement of the time that the participant takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Symptoms of Parkinson's disease
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Movement disorders society unified disease rating scale (MDS-UPDRS). Scores range from 0 to 199, with a higher score indicating a more severe impairment related to Parkinson's disease.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Quality of sleep
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Fear of falling
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Subjective level of physical activity
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Longitudinal Aging Study Amsterdam (LASA) Physical Activity Questionnaire (LAPAQ). Score corresponds to time spend doing physical activities. A higher score indicates a more active last two weeks.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Cardiovascular autonomic symptoms
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Selected cardiovascular questions from the Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT). Scored 0 to 9, a worse score means more symptoms of orthostatic hypotension.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Experienced quality of life
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Quality of life questionnaire: the Parkinson's disease questionnaire (PDQ-39). Scores range from 0 to 100, with a higher score indicating a worse quality of life.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Experienced anxiety and depression
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Quality of life questionnaire: the hospital anxiety and depression scale (HADS). Scores range from 0 to 21 for depression and anxiety, a score between 0-7 means no anxiety or depression, 8-14 possibility of an anxiety or depressive disorder and 15-21 likely a depressive or anxiety disorder.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Mental health
Time Frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Quality of life questionnaire: the Mental Health Continuum-Short Form (MHC-SF). Scores range from 0 to 70, with a higher score meaning a better emotional wellbeing.
Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leiden University Medical Center
Michael J. Fox Foundation for Parkinson's Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roland D Thijs, MD, PhD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL.80610.091.22
  • MJFF-020200 (Other Grant/Funding Number: Michael J Fox Foundation for Parkinson's Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Relevant and anonymized research data will be shared in the validated research database DANS Easy (Data Archiving and Networked Services). It will also be shared with the funding foundation (MJFF).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings