Sleep Apnea, Obstructive Clinical Trial
— POSAOfficial title:
Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to Assess the Effect on Health and Wellbeing in Older and Younger People
NCT number | NCT04153240 |
Other study ID # | 252494 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2019 |
Est. completion date | March 1, 2023 |
Verified date | March 2023 |
Source | Royal Brompton & Harefield NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aintree Hospital | Liverpool | |
United Kingdom | Royal Brompton Hospital | London | |
United Kingdom | The Royal Free Hospital | London | |
United Kingdom | The Freeman Hospital | Newcastle | |
United Kingdom | Churchill Hospital | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
Royal Brompton & Harefield NHS Foundation Trust | National Institute for Health Research, United Kingdom, University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of age on treatment effect, and on changes in AHI | A change from baseline to 3 months post Positional Therapy, compared to sham-treated controls, in older compared to younger patients in AHI | 3 months | |
Primary | 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 | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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). | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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 |
3 months | |
Secondary | 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) |
3 months |
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