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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06928766




Registration number
NCT06928766
Ethics application status
Date submitted
7/04/2025
Date registered
15/04/2025

Titles & IDs
Public title
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
Scientific title
Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.
Secondary ID [1] 0 0
1196261
Secondary ID [2] 0 0
7849
Universal Trial Number (UTN)
Trial acronym
ELOSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
OSA - Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eszopiclone 3 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Lemborexant 10mg

Experimental: Eszopiclone 3mg and lemborexant 10mg - Both Eszopiclone 3mg and Lemborexant 10mg in the form of capsules taken before bedtime. Dosages is taken on one instance for one night only.

Placebo comparator: Placebo - Placebo capsules that look exactly like the study drugs, taken before bedtime. Dosage is taken on one instance for one night only.


Treatment: Drugs: Eszopiclone 3 mg
Both eszopiclone and lemborexant taken together at bedtime for one night

Treatment: Drugs: Placebo
Placebo sugar pills that looks like the eszopiclone and lemborexant capsules taken at bedtime for one night.

Treatment: Drugs: Lemborexant 10mg
Both eszopiclone and lemborexant taken together at bedtime for one night
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in OSA severity (eszopiclone and lemborexant night vs. placebo night)
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [1] 0 0
Change in nadir overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [2] 0 0
Change in mean overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)
Timepoint [2] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [3] 0 0
Change in time below 90% blood arterial oxygen saturation (eszopiclone and lemborexant night vs. placebo night)
Timepoint [3] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [4] 0 0
Change in sleep efficiency (eszopiclone and lemborexant night vs. placebo night)
Timepoint [4] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [5] 0 0
Change in arousal index (eszopiclone and lemborexant night vs. placebo night)
Timepoint [5] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [6] 0 0
Change in respiratory control (eszopiclone and lemborexant night vs. placebo night)
Timepoint [6] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [7] 0 0
Change in the respiratory arousal threshold (eszopiclone and lemborexant night vs. placebo night)
Timepoint [7] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [8] 0 0
Change in airway collapsibility (eszopiclone and lemborexant night vs. placebo night)
Timepoint [8] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [9] 0 0
Change in pharyngeal muscle response (eszopiclone and lemborexant night vs. placebo night)
Timepoint [9] 0 0
Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [10] 0 0
Baseline OSA endotype and whether they are associated with changes in OSA severity
Timepoint [10] 0 0
Baseline sleep study
Secondary outcome [11] 0 0
Change in next morning balance (eszopiclone and lemborexant night vs. placebo night)
Timepoint [11] 0 0
Next morning following two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [12] 0 0
Change in perceived sleepiness (eszopiclone and lemborexant night vs. placebo night)
Timepoint [12] 0 0
Next morning following two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [13] 0 0
Change in driving simulator performance (eszopiclone and lemborexant night vs. placebo night)
Timepoint [13] 0 0
Next morning following two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
Secondary outcome [14] 0 0
Change in psycho-motor vigilance (eszopiclone and lemborexant night vs. placebo night)
Timepoint [14] 0 0
Next morning following two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

Eligibility
Key inclusion criteria
* Moderate or more difficulty "staying or initiating asleep" score on the Insomnia Severity Index questionnaire
* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index = 10 events/hour
* Low arousal respiratory threshold OSA endotype
* BMI =35 kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant
* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
* Current pregnancy or breast-feeding
* Current or recent other medical conditions likely to affect results or safety

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University, Adelaide Institute for Sleep Health - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Danny J Eckert, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Danny J Eckert, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8 7421 9780
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06928766