Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping

NCT06928766 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 78491196261
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches. People get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold). Accordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).

Conditions

OSA - Obstructive Sleep Apnea

Keywords

sleep disordered breathing; arousal; COMISA

Outcome Measures

Primary Outcomes (1)

• Change in OSA severity (eszopiclone and lemborexant night vs. placebo night)

  OSA severity as measured by the apnoea hypopnea index (units: number of respiratory events/h sleep) during overnight in-laboratory polysomnography.

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

Secondary Outcomes (14)

• Change in nadir overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

• Change in mean overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

• Change in time below 90% blood arterial oxygen saturation (eszopiclone and lemborexant night vs. placebo night)

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

• Change in sleep efficiency (eszopiclone and lemborexant night vs. placebo night)

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

• Change in arousal index (eszopiclone and lemborexant night vs. placebo night)

  Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.

Study Arms (2)

Eszopiclone 3mg and lemborexant 10mg

EXPERIMENTAL

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

Drug: Eszopiclone 3 mg; Drug: Lemborexant 10mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Eszopiclone 3 mg DRUG

Both eszopiclone and lemborexant taken together at bedtime for one night

Also known as: Lunesta

Eszopiclone 3mg and lemborexant 10mg

Placebo DRUG

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

Also known as: Sugar pill

Placebo

Lemborexant 10mg DRUG

Both eszopiclone and lemborexant taken together at bedtime for one night

Also known as: Dayvigo

Eszopiclone 3mg and lemborexant 10mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flinders University: lead

Study Sites (1)

Flinders University, Adelaide Institute for Sleep Health

Bedford Park, South Australia, 5042, Australia

Location

Related Publications (29)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Eszopiclone; Sugars; lemborexant

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Carbohydrates

Study Officials

• Danny J Eckert, PhD

  Flinders University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny J Eckert, PhD

CONTACT

+61 8 7421 9780; danny.eckert@flinders.edu.au

Cricket SB Fauska, BA

CONTACT

+61 8 8201-2706; cricket.fauska@flinders.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adelaide Institute for Sleep Health, Professor, College of Medicine and Public Health and Matthew Flinders Fellow, Flinders University

Model Details: Oral capsules (Eszopiclone 3mg and lemborexant 10mg) taken together or placebo equivalent , order is randomized. After at least a week washout the opposite agent will be given.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

AU (1)