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The POSA Trial - Positional Therapy for Positional OSA (POSA)

Primary Purpose

Sleep Apnea, Obstructive, Positional Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Positional Therapy, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥18
  • Ability and willingness to provide informed consent
  • AHI >5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep >20, <90% of total sleep; central apnoeas <20% total apnoeas; recording of ≥4 hours of analysable signals
  • Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation

Exclusion Criteria:

  • Unstable cardiac disease
  • Cardiac arrhythmia corrected with an artificial pacemaker
  • Supplemental oxygen
  • Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
  • Concerns about sleepy driving or any other potentially dangerous symptom from physician
  • BMI ≥40 Kilogram/m2
  • Inability to sleep in a non-supine position
  • Skin sensitivity or an open wound around neck
  • Neck circumference <12inches (30cm) or > 22inches (55cm)
  • Tics or tremors of the head
  • Sleep with head in upright position
  • A female of child-bearing potential that is pregnant or intends to become pregnant

Sites / Locations

  • Churchill Hospital
  • Aintree Hospital
  • The Royal Free Hospital
  • Royal Brompton Hospital
  • The Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Positional Therapy

Sham Positional Therapy

Arm Description

The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'THERAPY' mode (ie. vibration feedback will be given in response to supine position)

The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'MONITOR' mode (ie. no vibration feedback will be given)

Outcomes

Primary Outcome Measures

Change in OSA severity defined by Apnoea-Hypopnoea Index (AHI): Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy(events/hour)
Apnoea-hypopnea Index (AHI) (events/hour) measured by overnight polygraphy; 0 to <5 events/hour is no OSA, >=5 to <15 events/hour is mild OSA, >=15to <30 events/hour is moderate OSA, >=30 events/hour is severe OSA; Lower AHI is an improvement in disease

Secondary Outcome Measures

Change in AHI (events/hr) in younger (18-<65yrs) compared to older (>=65years) patients: Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy, in older compared to younger
Apnoea-hypopnea Index (AHI) (events/hour) measured by overnight polygraphy; 0 to <5 events/hour is no OSA, >=5 to <15 events/hour is mild OSA, >=15to <30 events/hour is moderate OSA, >=30 events/hour is severe OSA; Lower AHI is an improvement in disease
Changes in Subjective sleepiness: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale; 8 scenarios with the likeliness of falling asleep scored in each scenario from 0-3. The 8 Likert response items are summed to calculate a total score. Score range is 0 -24, with higher scores indicating greater daytime sleepiness. Scores >=11 are generally considered abnormal, or positive for excessive daytime sleepiness (EDS).
Changes in Quality of Life - measured by Functional Outcomes of Sleep Questionnaire (FOSQ); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in FOSQ
Functional Outcomes of Sleep Questionnaire (FOSQ) contains 30 items with 5 subscales (scored from 0-4 or 0-6 each). an average score is calculated for each subscale, and the 5 subscales are totaled to produce a total score.Score range is 5-20 points, with higher scores indicating better functional status.
Changes in Anxiety and Depression: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in the Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Scores of 8-10 indicate mild disease; 11-14 moderate and 15 to 21 severe. A reduction is considered an improvement in Anxiety or Depression.
Changes in Independent Functioning: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Townsend Disability Scale
The Townsend disability scale (McGee et al., 1998) is a short index of activities that assesses physical ability in social terms. The scale consists of nine questions or 'items'. The valid responses - 'yes, with no difficulty', 'yes, with some difficulty' and 'no, needs help'-score 0, 1 and 2 respectively. The scale gives equal weighting to each item. Townsend formed groups to interpret the scale (Townsend, 1979): a total score of 0 was regarded as indicating no disability, 1-2 being slightly affected, 3-6 having some disability, 7-10 having appreciable disability, 11-14 having severe disability and 15-18 having very severe disability.
Changes in Quality of Life measured by the Short-form 36 (SF-36); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in SF-36
The SF-36 questionnaire has 36 items dividing into 8 scales and then again into 2 components (mental and physical). The SF-36 consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Sores out of 100 are presented for the 8 scales and 2 components
Changes in subjective sleep quality and bed partner's perspective: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): 19 items across 7 components are included in scoring. 5 additional items, to be completed by a bed partner, are included in the questionnaire but are not used for scoring. Each of the 7 component scores is determined based on scoring algorithms, with the 7 component scores each yielding a score of 0 -3. A PSQI global (total) score is obtained by summing each of the 7 component scores. Scoring algorithms for each component involve a mixture of averaging Likert response scores, categorization of free text responses (e.g., sleep latency of 15-30 minutes = 1 point), and arithmetic determination of sleep efficiency based on free-text responses. Score range is 0 -21 points, with higher scores indicating better sleep quality.
Changes in Healthcare Utilisation measured by a Healthcare Utilisation Questionnaire
• Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Healthcare Utilisation Questionnaire
Comfort and tolerance of the Positional Therapy device
• Visual analogue scale (VAS) of comfort and tolerance of device. The scale is a 100mm line with 0 representing low comfort and tolerance and 100 representing high comfort and tolerance
Adherence to Positional Therapy measured by the Night Shift device
• Adherence to positional therapy measured by the Night Shift device will be reported as mean hrs/night over the entire 3 months. Good adherence for other OSA therapies, including CPAP, is suggested by an arbitrary threshold over >4 hours/night.
Changes to Sleeping position measured by the Night Shift device on the first (monitoring night) and last night of Therapy
• A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls NightShift data: - percentage supine sleep compared to total sleep time (in previous populations, a reduction of supine sleep time by 84% is a good outcome) A reduction in the supine sleep is an improvement
Changes in sleep-disordered breathing measured by overnight polygraphy
• A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls, in oxygenation measured by: -oxygen desaturation index (ODI; events/hour); measured by the number of overnight desaturations >3% and >4% as an index per hour An improvement is indicated by a reduction in ODI (normal is <5 events/hr)

Full Information

First Posted
September 2, 2019
Last Updated
March 29, 2023
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04153240
Brief Title
The POSA Trial - Positional Therapy for Positional OSA
Acronym
POSA
Official Title
Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vibro-tactile feedback may be beneficial for some patients, who have positional obstructive sleep apnoea (OSA). Aim: to determine whether Positional Therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional OSA, in reducing the disease severity and associated symptoms, compared to Sham-Positional Therapy. The interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age. Methods: A prospective randomised, parallel, double-blinded trial comparing Positional Therapy (Night Shift™; Advanced Brain Monitoring, USA) with Sham-Positional Therapy, performed in older (>65 years) and younger patients with positional OSA (apnoea/hypopnea index (AHI)>5 events/hour, 2:1 when supine). The primary endpoint, AHI at 3 months, will be measured by a repeat study with the device in situ, and compared between Positional Therapy and Sham-Positional Therapy. Patients' subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. Adherence to therapy will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Positional Sleep Apnea
Keywords
Positional Therapy, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised, parallel, double-blinded trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Devices are pre-programmed and by the central site by an unblinded researcher. Devices are allocated randomly by an online randomisation schedule. Researchers and participants, and the central Sleep Therapist remain blinded.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positional Therapy
Arm Type
Experimental
Arm Description
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'THERAPY' mode (ie. vibration feedback will be given in response to supine position)
Arm Title
Sham Positional Therapy
Arm Type
Sham Comparator
Arm Description
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) - set in 'MONITOR' mode (ie. no vibration feedback will be given)
Intervention Type
Device
Intervention Name(s)
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)
Other Intervention Name(s)
Positional Therapy
Intervention Description
The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) has been developed for adult patients with positional OSA, and snorers. Worn on the back of the neck, it begins to vibrate when the patient starts to sleep in the supine position and increases in intensity until the patient changes.
Primary Outcome Measure Information:
Title
Change in OSA severity defined by Apnoea-Hypopnoea Index (AHI): Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy(events/hour)
Description
Apnoea-hypopnea Index (AHI) (events/hour) measured by overnight polygraphy; 0 to <5 events/hour is no OSA, >=5 to <15 events/hour is mild OSA, >=15to <30 events/hour is moderate OSA, >=30 events/hour is severe OSA; Lower AHI is an improvement in disease
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in AHI (events/hr) in younger (18-<65yrs) compared to older (>=65years) patients: Final AHI after 3 months (adjusted for baseline AHI) of patients treated with Positional Therapy, compared to Sham-Positional Therapy, in older compared to younger
Description
Apnoea-hypopnea Index (AHI) (events/hour) measured by overnight polygraphy; 0 to <5 events/hour is no OSA, >=5 to <15 events/hour is mild OSA, >=15to <30 events/hour is moderate OSA, >=30 events/hour is severe OSA; Lower AHI is an improvement in disease
Time Frame
3 months
Title
Changes in Subjective sleepiness: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Epworth Sleepiness Scale (ESS)
Description
Epworth Sleepiness Scale; 8 scenarios with the likeliness of falling asleep scored in each scenario from 0-3. The 8 Likert response items are summed to calculate a total score. Score range is 0 -24, with higher scores indicating greater daytime sleepiness. Scores >=11 are generally considered abnormal, or positive for excessive daytime sleepiness (EDS).
Time Frame
3 months
Title
Changes in Quality of Life - measured by Functional Outcomes of Sleep Questionnaire (FOSQ); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in FOSQ
Description
Functional Outcomes of Sleep Questionnaire (FOSQ) contains 30 items with 5 subscales (scored from 0-4 or 0-6 each). an average score is calculated for each subscale, and the 5 subscales are totaled to produce a total score.Score range is 5-20 points, with higher scores indicating better functional status.
Time Frame
3 months
Title
Changes in Anxiety and Depression: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in the Hospital Anxiety and Depression Scale (HADS)
Description
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Scores of 8-10 indicate mild disease; 11-14 moderate and 15 to 21 severe. A reduction is considered an improvement in Anxiety or Depression.
Time Frame
3 months
Title
Changes in Independent Functioning: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Townsend Disability Scale
Description
The Townsend disability scale (McGee et al., 1998) is a short index of activities that assesses physical ability in social terms. The scale consists of nine questions or 'items'. The valid responses - 'yes, with no difficulty', 'yes, with some difficulty' and 'no, needs help'-score 0, 1 and 2 respectively. The scale gives equal weighting to each item. Townsend formed groups to interpret the scale (Townsend, 1979): a total score of 0 was regarded as indicating no disability, 1-2 being slightly affected, 3-6 having some disability, 7-10 having appreciable disability, 11-14 having severe disability and 15-18 having very severe disability.
Time Frame
3 months
Title
Changes in Quality of Life measured by the Short-form 36 (SF-36); Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in SF-36
Description
The SF-36 questionnaire has 36 items dividing into 8 scales and then again into 2 components (mental and physical). The SF-36 consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Sores out of 100 are presented for the 8 scales and 2 components
Time Frame
3 months
Title
Changes in subjective sleep quality and bed partner's perspective: Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Pittsburgh Sleep Quality Index (PSQI)
Description
Pittsburgh Sleep Quality Index (PSQI): 19 items across 7 components are included in scoring. 5 additional items, to be completed by a bed partner, are included in the questionnaire but are not used for scoring. Each of the 7 component scores is determined based on scoring algorithms, with the 7 component scores each yielding a score of 0 -3. A PSQI global (total) score is obtained by summing each of the 7 component scores. Scoring algorithms for each component involve a mixture of averaging Likert response scores, categorization of free text responses (e.g., sleep latency of 15-30 minutes = 1 point), and arithmetic determination of sleep efficiency based on free-text responses. Score range is 0 -21 points, with higher scores indicating better sleep quality.
Time Frame
3 months
Title
Changes in Healthcare Utilisation measured by a Healthcare Utilisation Questionnaire
Description
• Final scores after 3 months (adjusted for baseline scores) of patients treated with Positional Therapy, compared to sham-treated controls, in Healthcare Utilisation Questionnaire
Time Frame
3 months
Title
Comfort and tolerance of the Positional Therapy device
Description
• Visual analogue scale (VAS) of comfort and tolerance of device. The scale is a 100mm line with 0 representing low comfort and tolerance and 100 representing high comfort and tolerance
Time Frame
3 months
Title
Adherence to Positional Therapy measured by the Night Shift device
Description
• Adherence to positional therapy measured by the Night Shift device will be reported as mean hrs/night over the entire 3 months. Good adherence for other OSA therapies, including CPAP, is suggested by an arbitrary threshold over >4 hours/night.
Time Frame
3 months
Title
Changes to Sleeping position measured by the Night Shift device on the first (monitoring night) and last night of Therapy
Description
• A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls NightShift data: - percentage supine sleep compared to total sleep time (in previous populations, a reduction of supine sleep time by 84% is a good outcome) A reduction in the supine sleep is an improvement
Time Frame
3 months
Title
Changes in sleep-disordered breathing measured by overnight polygraphy
Description
• A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls, in oxygenation measured by: -oxygen desaturation index (ODI; events/hour); measured by the number of overnight desaturations >3% and >4% as an index per hour An improvement is indicated by a reduction in ODI (normal is <5 events/hr)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Effect of age on treatment effect, and on changes in AHI
Description
A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls, in older compared to younger patients in AHI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥18 Ability and willingness to provide informed consent AHI >5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep >20, <90% of total sleep; central apnoeas <20% total apnoeas; recording of ≥4 hours of analysable signals Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation Exclusion Criteria: Unstable cardiac disease Cardiac arrhythmia corrected with an artificial pacemaker Supplemental oxygen Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers Concerns about sleepy driving or any other potentially dangerous symptom from physician BMI ≥40 Kilogram/m2 Inability to sleep in a non-supine position Skin sensitivity or an open wound around neck Neck circumference <12inches (30cm) or > 22inches (55cm) Tics or tremors of the head Sleep with head in upright position A female of child-bearing potential that is pregnant or intends to become pregnant
Facility Information:
Facility Name
Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Aintree Hospital
City
Liverpool
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
The Freeman Hospital
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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The POSA Trial - Positional Therapy for Positional OSA

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