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Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome

Primary Purpose

Ehlers-Danlos Syndrome

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Oxygen
Placebo
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ehlers-Danlos Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • Aged ≥ 18 years;
  • Diagnosed with EDS/HT defined by the New York critieria;
  • With intense fatigue defined by an FSS ≥ 4;
  • Having given free and informed written consent;
  • Speaking french language;
  • Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

  • with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smoking emphysema);
  • having an ongoing pregnancy or breastfeeding;
  • who have already received oxygen therapy for the EDS / HT indication in the last 6 months;
  • having a pathology that causes fatigue, which is not compensated or treated; non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies including severe depression, organ failure (cardiac, renal, respiratory, hepatic), endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies;
  • Subject to a measure for the protection of justice.

Sites / Locations

  • Hopital Raymond PoincaréRecruiting
  • Clinique de la MitterieRecruiting
  • Hopital Saint JosephRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxygen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

FSS (Fatigue Severity Scale) score
FSS (Fatigue Severity Scale) score

Secondary Outcome Measures

PRISM (Pictorial Representation of Illness and Self Measure) score
SF-36 quality of life questionnaire (Short Form Heath Survey) score
TSK (Tampa Scale Kinesiophobia) score
walk test results
HIT-6 (Headache Impact Test) score
NQ (Nijmegen questionnaire ) score
Epworth Sleepiness score
PSQI (Pittsburgh sleep quality index) score
HADS (Hospital Anxiety and Depression Scale) score
NYHA (New Year Heart Association) score
consumption of care
The consumption of care is defined by the presence of at least one major criterion associated or not with the minor criterion: Major criteria: Variation of at least one level in the frequency of use and / or in the duration of use compared to the baseline assessment concerning the use of flexible and / or rigid orthoses, Variation of at least one level of the analgesic levels used compared to the baseline assessment for pain relievers. Variation of at least one level in frequency compared to the baseline assessment for physiotherapy sessions. Minor criterion: Variation of the total daily dose compared to the baseline assessment for painkillers.
Number of oxygen therapy sessions followed by the patient

Full Information

First Posted
May 6, 2021
Last Updated
March 15, 2022
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT04890431
Brief Title
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome
Official Title
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The hypothesis of the OXYSED study is that the delivery of 3 months of oxygen therapy via an oxygen concentrator would reduce fatigue, pain, headaches, kinesiophobia, drug intake, dyspnea, and improve walking performance, quality of sleep and quality of life of patients with Ehlers Danlos syndrome hypermobility type (EDS / HT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ehlers-Danlos Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygen
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)
Primary Outcome Measure Information:
Title
FSS (Fatigue Severity Scale) score
Time Frame
7 months
Title
FSS (Fatigue Severity Scale) score
Time Frame
10 months
Secondary Outcome Measure Information:
Title
PRISM (Pictorial Representation of Illness and Self Measure) score
Time Frame
7 and 10 months
Title
SF-36 quality of life questionnaire (Short Form Heath Survey) score
Time Frame
7 and 10 months
Title
TSK (Tampa Scale Kinesiophobia) score
Time Frame
7 and 10 months
Title
walk test results
Time Frame
7 and 10 months
Title
HIT-6 (Headache Impact Test) score
Time Frame
7 and 10 months
Title
NQ (Nijmegen questionnaire ) score
Time Frame
7 and 10 months
Title
Epworth Sleepiness score
Time Frame
7 and 10 months
Title
PSQI (Pittsburgh sleep quality index) score
Time Frame
7 and 10 months
Title
HADS (Hospital Anxiety and Depression Scale) score
Time Frame
7 and 10 months
Title
NYHA (New Year Heart Association) score
Time Frame
7 and 10 months
Title
consumption of care
Description
The consumption of care is defined by the presence of at least one major criterion associated or not with the minor criterion: Major criteria: Variation of at least one level in the frequency of use and / or in the duration of use compared to the baseline assessment concerning the use of flexible and / or rigid orthoses, Variation of at least one level of the analgesic levels used compared to the baseline assessment for pain relievers. Variation of at least one level in frequency compared to the baseline assessment for physiotherapy sessions. Minor criterion: Variation of the total daily dose compared to the baseline assessment for painkillers.
Time Frame
7 and 10 months
Title
Number of oxygen therapy sessions followed by the patient
Time Frame
7 and 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18 years; Diagnosed with EDS/HT defined by the New York critieria; With intense fatigue defined by an FSS ≥ 4; Having given free and informed written consent; Speaking french language; Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smoking emphysema); having an ongoing pregnancy or breastfeeding; who have already received oxygen therapy for the EDS / HT indication in the last 6 months; having a pathology that causes fatigue, which is not compensated or treated; non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies including severe depression, organ failure (cardiac, renal, respiratory, hepatic), endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies; Subject to a measure for the protection of justice.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Bielmann
Phone
04 88 73 10 70
Ext
0033
Email
cbielmann@hopital-saint-joseph.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Bienvenu
Organizational Affiliation
Hopital Saint Joseph Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Raymond Poincaré
City
Garches
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonidas Degila
First Name & Middle Initial & Last Name & Degree
Karelle Benistan, M.D
Facility Name
Clinique de la Mitterie
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada El Fazazy
First Name & Middle Initial & Last Name & Degree
Cyril Bergoin, M.D
Facility Name
Hopital Saint Joseph
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Bielmann
First Name & Middle Initial & Last Name & Degree
Boris Bienvenu, M.D

12. IPD Sharing Statement

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Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome

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