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Assessment of Desogestrel in Ondine Syndrome (RESPIRONDINE)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: November 17, 2010
Last updated: November 13, 2013
Last verified: October 2012

The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is a very rare genetic disorder. In contrast with healthy people, patients do not increase breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not breath sufficiently, or even stop breathing, during sleep. Their survival depends only on mechanical respiratory assistance, all life long.

We have recently published two cases of recovery of a response to CO2 in patients taking desogestrel as a contraceptive pill. The goal of the study is therefore to assess the hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and allow them to breath sufficiently during sleep without mechanical assistance.

Condition Intervention Phase
Ondine Syndrome Drug: desogestrel Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Increase in the ventilatory response to hypercapnia [ Time Frame: 112 days ]

Secondary Outcome Measures:
  • Ventilatory response to hypoxia [ Time Frame: 112 days ]
  • Activation of new cerebral regions in fMRI [ Time Frame: 112 days ]
  • Weaning from mechanical ventilation during sleep [ Time Frame: 112 days ]

Enrollment: 6
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: desogestrel
Tablets of 75 µg, once daily during 112 days
Drug: desogestrel
Tablets of 75 µg, once daily during 112 days

  Show Detailed Description


Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Ondine syndrome
  • Pubescent female

Exclusion criteria :

  • Contra-indications to a treatment with desogestrel.
  • Other treatment with estrogens or progestin that cannot be stopped.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01243697

Pitie salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: STRAUS Christian, MD, PhD Pitie Salpetriere Hospital (APHP)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01243697     History of Changes
Other Study ID Numbers: P101001
Study First Received: November 17, 2010
Last Updated: November 13, 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Sleep Apnea, Central
Pathologic Processes
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 20, 2017