Obstructive Sleep Apnea of AdultPhase 1NCT05458193
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
A Phase 1 study testing Daridorexant in people with Obstructive Sleep Apnea of Adult, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial summary
A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 17 Aug 2022to 28 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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pressure (CPAP) device or a dental appliance device for the treatment of OSA must either not have started it or have withdrawn from it at least 2 months before randomization in this study.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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Daridorexant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Also called ACT-541468
Film-coated tablet for oral use
PlaceboDrug
Film-coated tablet for oral use
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | 50 mg once daily from Day 1 to Day 5 Receives: Drug: Daridorexant |
| Placebo | Placebo comparator | Matching placebo once daily from Day 1 to Day 5 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Night 5 of period 1 and period 2 (Total duration: 2 days)
Secondary outcomes (4)
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.
Measured: Night 5 of period 1 and period 2 (Total duration: 2 days)
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.
Measured: Night 5 of period 1 and period 2 (Total duration: 2 days)
Daridorexant plasma concentration
Measured: 9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)
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.
Measured: Day 1 up to Day 13 (Total duration: 13 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start17 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-way cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458193
- Sponsor's protocol ID
- ID-078-121
- Other IDs
- 2022-000098-23
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fietze I, Boof ML, Lederer K, Lemoine V, Vaillant C, Pepin JL. Daridorexant in severe obstructive sleep apnea: Effects on sleep-disordered breathing and sleep. Sleep. 2026 May 22:zsag145. doi: 10.1093/sleep/zsag145. Online ahead of print.
PubMed 42171662
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05458193
- Acronym / sponsor ID
- ID-078-121
- Conditions
- Obstructive Sleep Apnea of Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-way cross-over
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: Daridorexant50 mg once daily from Day 1 to Day 5 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo once daily from Day 1 to Day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantAlso: ACT-541468Film-coated tablet for oral use | Drug | Daridorexant |
| PlaceboFilm-coated tablet for oral use | Drug | Placebo |
Primary outcome
Treatment difference (daridorexant - placebo) for apnea/hypopnea index
Time frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
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.
4 secondary outcomes
Treatment difference (daridorexant - placebo) in mean peripheral oxygen saturation (SpO2) during total sleep time
Time frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
Treatment difference (daridorexant - placebo) for total sleep time
Time frame: Night 5 of period 1 and period 2 (Total duration: 2 days)
Daridorexant plasma concentration
Time frame: 9 hours post-dose on Day 2 and Day 6 (Total duration: up to 2 days)
Incidence of treatment-emergent adverse events
Time frame: Day 1 up to Day 13 (Total duration: 13 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 42171662Fietze I, Boof ML, Lederer K, Lemoine V, Vaillant C, Pepin JL. Daridorexant in severe obstructive sleep apnea: Effects on sleep-disordered breathing and sleep. Sleep. 2026 May 22:zsag145. doi: 10.1093/sleep/zsag145. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea of Adult
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daridorexant in people with Obstructive Sleep Apnea of Adult, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment difference (daridorexant - placebo) for apnea/hypopnea index (time frame: Night 5 of period 1 and period 2 (Total duration: 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.