Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05263349 |
| Other study ID # |
APHP220143 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
October 15, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Sleep is a fundamental period in life. In a previous work, the investigators have shown that
COPD patients presented on the EEG figures found in patients with chronic pain: Alpha-Delta.
The link between dyspnea and pain is very strong and this Alpha-Delta could, in these COPD
patients, be the witness of nocturnal dyspnea.
Although it is not possible in a non-awake patient to evaluate reliably the dyspnea, sleep
offers us a window on the emotions and the feeling of the patient: Dreams.
A few studies have shown the link between breathing and dreaming, but none of them has
focused on nocturnal dyspnea.
Our working hypothesis is that respiratory abnormalities in COPD patients are responsible for
nocturnal dyspnea, which is reflected in the content of these patients' dreams.
Description:
Sleep is a fundamental period for maintaining homeostasis and ensuring many vital functions.
It is crucial for brain development, memory and the preservation of our cognitive abilities.
It is essential for the adjustment of numerous hormonal secretions, for glycemic control and
for the efficiency of our immune system. Today, it is assumed that the reduction of sleep
time or the alteration of its quality favors weight gain and obesity, the appearance of
diabetes or the development of cancerous diseases. This is a major issue for our modern
societies
In patients with respiratory diseases, and in particular with chronic obstructive pulmonary
disease (COPD), sleep complaints are extremely frequent. Thus, patients with COPD have
subjectively and objectively impaired sleep quality with a lower efficiency and a decrease in
the amount of deep slow wave sleep. Moreover, the alteration of the quality of sleep and the
physiological modifications of the ventilation during it, worsen the respiratory state of
these patients, with an increase of the alveolar hypoventilation, an alteration of the
quality of life and an increased risk of exacerbation. A preliminary work of our team was
interested in the study of this sleep-breathing relationship and its impact in COPD patients.
Twenty-nine COPD patients hospitalized after respiratory exacerbation were examined by
polysomnography. The most striking features were the presence of short (median 328 min,
IQR25-75 [299-414]) and poor quality sleep (median Efficiency at 66% IQR 28-75 [51-78]). The
sleep architecture was extremely disturbed with notably a decrease in the duration of deep
slow-wave sleep with 85 minutes of N3 in median, IQR 25-75 [62-111]. In 3 patients, there was
even a complete absence of REM sleep (SP). However, these results only confirmed the data in
the literature on the study of sleep in COPD patients.
However, this work has allowed us to highlight 2 other anomalies 1- the demonstration of an
electromyographic activation of the cervical inspiratory muscles (MIC) (sternocleidomastoid
and scalene) in 26 out of 29 patients during sleep. Activation which, for half of the cases,
is not present during wakefulness and only appears during sleep. Moreover, this activation
was even present during REM sleep in 9 patients, whereas REM sleep is defined by an abolition
of muscle tone. 2- The presence of Alpha Delta on the EEG. This phenomenon has already been
observed in patients with chronic pain and is, according to the authors, a sign of cortical
integration of pain during sleep.
Dyspnea, or "unpleasant breathlessness", is an abnormal and uncomfortable perception of
breathing. The experience of dyspnea is the result of multiple interactions between
physiological and environmental factors: it is a complex symptom that signals a threat to
homeostasis, frequently inducing an adaptive behavioral response, which is not always
efficient. It is responsible for a suffering whose mechanisms and perception can be similar
to those of pain. Dyspnea is a subjective sensation with a sensory component and an affective
component.
Patients suffering from chronic respiratory disease and in particular COPD very frequently
present this symptom of dyspnea on awakening. But during the night, several arguments plead
for the persistence of this dyspnea: the activation of the accessory muscles at the cervical
level is associated with this sensation of dyspnea and the presence of Alpha Delta at the
EEG, known to be a sign of pain during sleep, could in this case be a sign of dyspnea,
indeed, the mechanisms of the perception of pain and dyspnea are close.
Although it is often studied, especially in intensive care unit with sedated patients, there
is no tool to evaluate dyspnea in non-awake patients. However, sleep is not a state similar
to coma or sedation. As everyone knows, sleep is accompanied by a unique cognition: dreams.
The scientific term dream includes thoughts, images, sounds, sensations or emotions occurring
during sleep.
The link between dreams and breathing has already been established in 2 studies. In the first
one, Oudiette et al. showed in lucid dreamers an interaction between the content of their
dream (Crossing a nauseating city) and breathing (Apnea preceded by a deep inspiration,
witnessing a cortical preparation). Carrasco et al. have shown that the quantity of dreams
and their content were related to the effectiveness of the treatment in apneic subjects. The
investigators can therefore hypothesize that if patients have respiratory abnormalities
responsible for nocturnal dyspnea, these could be reflected in their dreams.
COPD is one of the most frequent respiratory pathologies in France and in the world. The WHO
forecasts that it will be the 3rd cause of death in 2030. The study of COPD is therefore a
priority, and it is one of the chronic diseases referenced by the Ministry of Solidarity and
Health in its national health strategy 2018-2022.
In order to have a comparable control group, patients will be matched to a group of healthy
subjects of the same sex and age.
The investigators dream all night long but there is still a difference between dream activity
in MS and slow wave sleep. Thus, compared to slow wave sleep, dreams reported after waking up
in MS are typically longer, more vivid, more animated (more movement), more emotionally
charged and less related to waking experiences. In contrast to MS dreams, slow wave sleep
dreams are more closely related to "thoughts" or representations of real life problems.
In this work, The investigators will study the dreams of the patients through 2 tools: a
questionnaire of typical dreams in order to have an evaluation of the content of the dreams
on the life of the patient (Cf Appendix) as well as a dream diary over 2 weeks to try to have
a precise description of the dreams of the patients.
There are no studies that have looked at the dreams of COPD patients. However, it seems
necessary to carry out a dream diary over several days in order to accustom the patient to
remember his dreams and to succeed in telling them. A duration of 2 weeks seems to be an
appropriate compromise between a sufficiently long time to allow relevant information to be
collected, without being too long and discouraging for the patients.
