Back to resultsA Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
Primary Purpose
Obstructive Sleep Apnea of Adult
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Daridorexant
Placebo
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea of Adult
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Male and female participants aged 18 years or older at Screening.
- Diagnosis of Obstructive Sleep Apnea (OSA) according to the International Classification of Sleep Disorders, documented by medical history and confirmed by a specialist.
- Severe intensity of OSA determined during OSA diagnosis and confirmed during both screening night polysomnography (PSG) and defined as apnea/hypopnea index greater than or equal to 30 events per hour.
- Patient who may require a continuous positive airway pressure (CPAP) device or a dental appliance device for the treatment of OSA must either not have started it or have withdrawn from it at least 2 months before randomization in this study. In all cases patients must not start using this type of device during the study.
- Women of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 and a negative urine pregnancy test on Day 1 pre-dose of the first study period. She must agree to consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
- Woman of non-childbearing potential, i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
Exclusion Criteria:
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Legal incapacity or limited legal capacity or vulnerability (e.g., kept in detention) at Screening.
- Pregnant or lactating woman.
- Modified Swiss Narcolepsy Scale total score less than 0 at Screening or history of narcolepsy or cataplexy.
- Participant with clinically significant abnormality present on either or both screening night PSG.
- Evidence of any other clinically significant active pulmonary disease such as chronic obstructive pulmonary disease (as per Global Initiative for Obstructive Lung Disease), based on investigator's judgment.
- History of surgical intervention for OSA, except nose surgery.
- Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff from study site or the sponsor directly involved in the conduct of the study or their relatives.
Sites / Locations
- ASR Advanced Sleep Research GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Daridorexant
Placebo
Arm Description
50 mg once daily from Day 1 to Day 5
Matching placebo once daily from Day 1 to Day 5
Outcomes
Primary Outcome Measures
Treatment difference (daridorexant - placebo) for apnea/hypopnea index
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by polysomnography.
Polysomnography recording will start at the time of "lights off" and last for 8 hours.
The apnea/hypopnea index is defined by the total number of apneas (pause in respiration ≥ 10 sec) plus hypopneas (peak signal excursions drop by ≥ 30% of pre-event baseline for at least 10 sec accompanied by a decrease of SpO2 ≥ 3% from pre-event baseline and/or the event is associated with an arousal) during total sleep time (TST), divided by TST (in min), then multiplied by 60.
Secondary Outcome Measures
Treatment difference (daridorexant - placebo) in mean peripheral oxygen saturation (SpO2) during total sleep time
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by pulse oximetry.
Pulse oximetry recording will start at the time of "lights off" and last for 8 hours.
Treatment difference (daridorexant - placebo) for total sleep time
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by polysomnography.
Polysomnography recording will start at the time of "lights off" and last for 8 hours.
Daridorexant plasma concentration
Incidence of treatment-emergent adverse events
A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Full Information
NCT ID
NCT05458193
First Posted
July 11, 2022
Last Updated
April 3, 2023
Sponsor
Idorsia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05458193
Brief Title
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
Official Title
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of Daridorexant on Nighttime Respiratory Function and Sleep in Patients With Severe Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).
Detailed Description
Each subject will participate in 2 study periods. Participants will receive 50 mg daridorexant in one period and placebo in the other period. Both periods will last from Day 1 (first administration) in the evening to Day 6 in the morning (defined as End-of-Period). The 2 periods will be separated by an in-between period of 1 to 2 weeks. An End-of-Study examination will take place 1 to 2 weeks after last administration of study treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
2-way cross-over
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daridorexant
Arm Type
Experimental
Arm Description
50 mg once daily from Day 1 to Day 5
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo once daily from Day 1 to Day 5
Intervention Type
Drug
Intervention Name(s)
Daridorexant
Other Intervention Name(s)
ACT-541468
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablet for oral use
Primary Outcome Measure Information:
Title
Treatment difference (daridorexant - placebo) for apnea/hypopnea index
Description
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by polysomnography.
Polysomnography recording will start at the time of "lights off" and last for 8 hours.
The apnea/hypopnea index is defined by the total number of apneas (pause in respiration ≥ 10 sec) plus hypopneas (peak signal excursions drop by ≥ 30% of pre-event baseline for at least 10 sec accompanied by a decrease of SpO2 ≥ 3% from pre-event baseline and/or the event is associated with an arousal) during total sleep time (TST), divided by TST (in min), then multiplied by 60.
Time Frame
Night 5 of period 1 and period 2 (Total duration: 2 days)
Secondary Outcome Measure Information:
Title
Treatment difference (daridorexant - placebo) in mean peripheral oxygen saturation (SpO2) during total sleep time
Description
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by pulse oximetry.
Pulse oximetry recording will start at the time of "lights off" and last for 8 hours.
Time Frame
Night 5 of period 1 and period 2 (Total duration: 2 days)
Title
Treatment difference (daridorexant - placebo) for total sleep time
Description
The treatment difference will be assessed at Night 5 of period 1 and period 2 after repeated-dose administration, as measured by polysomnography.
Polysomnography recording will start at the time of "lights off" and last for 8 hours.
Time Frame
Night 5 of period 1 and period 2 (Total duration: 2 days)
Title
Daridorexant plasma concentration
Time Frame
9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)
Title
Incidence of treatment-emergent adverse events
Description
A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time Frame
Day 1 up to Day 13 (Total duration: 13 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
Male and female participants aged 18 years or older at Screening.
Diagnosis of Obstructive Sleep Apnea (OSA) according to the International Classification of Sleep Disorders, documented by medical history and confirmed by a specialist.
Severe intensity of OSA determined during OSA diagnosis and confirmed during both screening night polysomnography (PSG) and defined as apnea/hypopnea index greater than or equal to 30 events per hour.
Patient who may require a continuous positive airway pressure (CPAP) device or a dental appliance device for the treatment of OSA must either not have started it or have withdrawn from it at least 2 months before randomization in this study. In all cases patients must not start using this type of device during the study.
Women of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 and a negative urine pregnancy test on Day 1 pre-dose of the first study period. She must agree to consistently and correctly use a highly effective method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
Woman of non-childbearing potential, i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
Exclusion Criteria:
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Legal incapacity or limited legal capacity or vulnerability (e.g., kept in detention) at Screening.
Pregnant or lactating woman.
Modified Swiss Narcolepsy Scale total score less than 0 at Screening or history of narcolepsy or cataplexy.
Participant with clinically significant abnormality present on either or both screening night PSG.
Evidence of any other clinically significant active pulmonary disease such as chronic obstructive pulmonary disease (as per Global Initiative for Obstructive Lung Disease), based on investigator's judgment.
History of surgical intervention for OSA, except nose surgery.
Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff from study site or the sponsor directly involved in the conduct of the study or their relatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
ASR Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
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