NCT05263349

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

February 21, 2022

Last Update Submit

October 27, 2023

Conditions

Keywords

DreamsSleep

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the dreams reported by the patient during 15 days

    analysis of the dream book filled in by the patient during 15 days

    15 days after inclusion

Secondary Outcomes (2)

  • Typical Dream Questionnaire

    to inclusion

  • HAD Scale

    to inclusion

Study Arms (2)

COPD patients

Arm with patients with respiratory disease in whom we study dreams

Other: Typical Dreams QuestionnaireOther: HAD QuestionnaireOther: Dream Booklet

healthy subject

Arm with healthy subjects whose dream analysis will be used as a basis to compare them to the dreams of COPD patients and see if the disease (COPD) has an influence on the patients' dreams

Other: Typical Dreams QuestionnaireOther: HAD QuestionnaireOther: Dream Booklet

Interventions

Each of the dreams was classified according to its thematic content (e.g., being involved in a chase, flying through the air, falling, being lost, losing one's teeth, drowning) in order to in a chase, flying through the air, falling, being lost, losing teeth, drowning) in order to determine the most determine the most frequent themes emerging from our sample. The instrument used used to carry out this classification is the "Typical Dream Questionnaire" of Zadra and Nielsen (1999), which has been validated with more than 600 patients suffering from sleep disorders and and 1200 adults (Nielsen et al., 1999; 2003).

COPD patientshealthy subject

The HAD scale is an instrument that screens for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D). two scores (maximum score for each score = 21).

COPD patientshealthy subject

The patient is asked to write down in a notebook every morning the description of the dreams made during the night and to comment on it if necessary

COPD patientshealthy subject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD hospitalized in the respiratory and neuro-respiratory follow-up and rehabilitation department (SSR) of the Pitié-Salpêtrière Hospital. Healthy subjects without respiratory disorders selected to participate in the study.

You may qualify if:

  • For both groups:
  • Age ≥ 18 years
  • Able to understand information and express non-opposition.
  • Information and non-opposition gathered
  • Affiliated with a social security system
  • For patients:
  • With confirmed COPD prior to hospitalization at the SRH
  • Hospitalized at the SSR of the Pitié-Salpêtrière Hospital

You may not qualify if:

  • For both groups:
  • Patient under constraint
  • Patient who cannot read or write French
  • Patient under AME For healthy subjects
  • Known respiratory pathology
  • Obesity with BMI \> 35 kg/m².
  • Known sleep apnea syndrome
  • Smoking \> 30 PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSR Respiratory and Neuro Respiratory

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

July 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 15, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations