Condition category
Respiratory
Date applied
16/03/2017
Date assigned
24/03/2017
Last edited
14/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breathing causes the trunk (torso) and ribcage to move. In some cases, this movement can cause unsteadiness and changes in posture and gait (pattern of movement of the limbs while moving). When a person is suffering from a long term respiratory (breathing disorder) this may have an effect on posture and gait (way of walking). Obstructive sleep apnoea syndrome (OSAS) is a common condition in which the upper airways (wind pipe) collapse repeatedly during sleep, stopping the flow of air into the lungs. This prevents the sufferer from being able to breathe properly while they are asleep, causing excessive sleepiness throughout their waking hours. Chronic obstructive pulmonary disease (COPD) is a condition which affects the lungs and is often caused by smoking. It is characterised by breathlessness, cough and excess mucus production. The aim of this study is to look analyse any possible problems with posture in patients suffering from OSAS or COPD.

Who can participate?
Patients with OSAS or COPD.

What does the study involve?
All participants attend, at least, three study visits. The first involves measuring lung volume by blowing into a machine called a spirometer and takes around two hours. The second visit takes around one hour for COPD patients and one hour and thirthy minutes for OSAS patients and involves completing questionnaires about sleep quality and mood and well as undergoing a physical examination. At the third visit, participants have 78 reflective markers attached to their whole body so that their motion can be monitored to assess their posture, and complete different breathing and cognitive patterns each in a standing position and then a sitting position. Participants also take part in a walking test to measure their gait (way of walking) speed during a real walking test and an imaginary walking test. The second part consists of the posture analysis which is measured by taking a series of pictures taken using low dose x-rays while they are breathing calmly, after taking a deep breath and after breathing out fully in both sitting and standing positions. OSAS patients are also able to attend two optional visits. At the first, at least two months after the third visit, in which the breathing tests from the third study visit are repeated. At the second, at least six months after the third visit, all of the measurements taken on the third visit are repeated.

What are the possible benefits and risks of participating?
There are no direct benefits and no significant risks involved with participating.

Where is the study run from?
1. Laboratoire de biomécanique humaine Georges charpak Arts et Métiers ParisTech (France)
2. Hôpital Pitié-Salpêtrière (France)

When is the study starting and how long is it expected to run for?
November 2016 to November 2019

Who is funding the study?
National School of Arts and Trades (France)

Who is the main contact?
Dr Valeria Attali
valerie.attali@aphp.fr

Trial website

Contact information

Type

Public

Primary contact

Dr Valérie Attali

ORCID ID

Contact details

Pitié-Salpêtrière Hospital
47-83 Boulevard de l'Hôpital
Paris
75013
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADOREPS_2017_P08

Study information

Scientific title

Study of interactions between posture, locomotion and breathing in patients with obstructive sleep apnoea syndrome (OSAS) and chronic obstructive pulmonary disease (COPD)

Acronym

RespiMeca2

Study hypothesis

1. In patients with obstructive sleep apnoea syndrome (OSAS), the postural dysfunction is centrally mediated
2. In patients with chronic obstructive pulmonary disease (COPD), the postural dysfunction is multi-factor (linked to the thoracic distension, linked to an abnormal ventilation with dyspnea and centrally mediated)

Ethics approval

Comité de Protection des Personnes Ouest V, 28/06/2017, ref: 17/018-2 and 2017-A00721-52

Study design

Single-centre non-randomised controlled study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

1. Obstructive sleep apnoea syndrome (OSAS)
2. Chronic obstructive pulmonary disease (COPD)

Intervention

Participants attend a total of five study visits. At the first study visit, after provision of informed consent, participants complete a range of spirometry tests. The visit lasts for a total of around two hours. At the second visit, participants complete a questionnaire about quality of sleep and their mood (anxiety, depression). They additionally undergo a cognitive check-up and an osteopathic examination. The visit takes around one hour for patients with COPD, and one and a half hours for OSAS patients, who also undergo a voice and prosody test with examination of face motricity which takes around thirty minutes.

If possible, OSAS patients stop their OSAS treatment (mandibular orthosis or CPAP) for 10 days before the third visit. On the third study visit, participants undergo a range of posture measurements using a force platform on the floor and motion capture. This involves having 78 reflective markers affixed to the body, including 35 on the thorax and the abdomen, so that motion capture can be undertaken using an optoelectronic VICON system to assess postural stability. Participants are instructed to perform different breathing and cognitive patterns each in standing position followed by sitting position. This process takes one hour.

The breathing patterns are:
1. Quiet breathing with open eyes and mouth for one minute
2. Quiet breathing with closed eyes and open mouth for one minute
3. Quiet breathing with eyes open and closed mouth for one minute
4. Quiet breathing with eyes and mouth closed for one minute
5. Sniff breathing during 30 seconds
6. Apnea at the CRF (after a normal expiration), VR (after a full expiration) and CPT (after a full inspiration)
7. Deep breathing for 30 seconds

The cognitive patterns are :
1.Quiet breathing and remember 5 two-digit multiplications for one minute and tell the result when the minute is finished
2.Quiet breathing and remember 8 words for one minute and tell them when the minute is finished

Gait velocity is measured using the stand up and go test. This involves participants sitting on a stool before being instructed to stand up and walk three meters before returning to the stool. This test takes approximately 10 minutes.

Gait velocity is measured using the stand up and go test. This involves participants sitting on a chair before being instructed to stand up and walk three meters before returning to the chair. This test takes approximately 10 minutes. Following this, dynamic axis is assessed by measuring angulations of posture using the EOS® system. For patients with COPD or patients with OSAS without any treatment or treated by CPAP, three pairs of images will be done in sitting position (during calm breathing, after a full inspiration and after a full expiration) , and three in standing position in the same conditions. For patients with OSAS treated by mandibular protrusion orthosis, four pairs of images will be done in standing position (during calm breathing, after a full inspiration and after a full expiration and the last during calm breathing with the orthosis), and two in sitting position (during calm breathing with and without orthosis). This process takes approximately 45 minutes.

Participants with OSAS are then given the option to return for a fourth study visit at least two months after the third study visit at which only the breathing and cognitive patterns are repeated , and then a fifth study visit at least 6 months after the third visit at which all the tests undertaken on the third visit are repeated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Postural stability is assessed using a force platform and motion capture taken by an optoelectronic VICON system on study visit 3 (as well as 4 and 5 for OSAS patients)

Secondary outcome measures

1. Angulations in posture is measured using the EOS® system on study visit 3 (as well as 4 and 5 for OSAS patients)
2. Gait velocity is measured using the stand up and go test on study visit 3 (as well as 4 and 5 for OSAS patients)

Overall trial start date

02/11/2016

Overall trial end date

02/11/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Moderate to severe OSAS diagnosed thanks to polysomnography
2. COPD diagnosed thanks to the symptoms and functionnal respiratory analysis
3. Aged 18 years and over
4. Should understand the informations and sign the consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients with OSAS and 30 patients with COPD

Participant exclusion criteria

1. Pregnant or nursing women (female patients)
2. Under judicial protection
3. If the subject realises an other study wich prohibits him to be involved in another study
4. Aged under 18 years

Recruitment start date

12/07/2017

Recruitment end date

02/11/2019

Locations

Countries of recruitment

France

Trial participating centre

Laboratoire de biomécanique humaine Georges charpak Arts et Métiers ParisTech
155 boulevard de l'hôpital
Paris
75013
France

Trial participating centre

Hôpital Pitié-Salpêtrière
47-83 boulevard de l'hôpital
Paris
75013
France

Sponsor information

Organisation

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil (ADOREPS)

Sponsor details

Hôpital Pitié Salpêtrière
47-83
Boulevard de l’Hôpital
Paris Cedex 13
75651
France

Sponsor type

Other

Website

Funders

Funder type

University/education

Funder name

National School of Arts and Trades (Ecole Nationale Supérieure d'Arts et Métiers)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Valérie Attali (valerie.attali@aphp.fr)

Intention to publish date

02/11/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/07/2017: The recruitment start date was changed from 12/04/2017 to 12/07/2017.