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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05551377

Collaborator

Leiden University Medical Center (Other), Michael J. Fox Foundation for Parkinson's Research (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Head-up tilt sleeping	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Masking Description:

Both the investigator and the participants are blinded to treatment allocation.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Average overnight supine blood pressure [Measured four times: in week 1, 3, 5 and 7]
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)

Secondary Outcome Measures

Daily supine blood pressure [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
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)]
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
24h ABPM parameters [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.
Orthostatic tolerance [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.
Nocturia [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))
Subjective comfort of HUTS (head up tilted sleeping) [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.
Falls [Week 1, 3, 5 and 7]
Self-reported falls and in case of a fall additional questions about the time and circumstances
Overnight change in body weight [Daily in week 1 up to and including week 7]
Weight (kg) difference between the evening and the morning, both measured after micturition
Nighttime urine production [Week 1, 3, 5 and 7]
Urine volume measured in a urinal (ml)
Barriers and facilitators of the intervention [Immediately post-intervention (day after week 7, T1)]
Structured interview

Other Outcome Measures

Timed up and go test (TUG) [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
Symptoms of Parkinson's disease [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.
Quality of sleep [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.
Fear of falling [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.
Subjective level of physical activity [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.
Cardiovascular autonomic symptoms [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.
Experienced quality of life [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.
Experienced anxiety and depression [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.
Mental health [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
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;