NCT01102270

Brief Summary

The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
7 years until next milestone

Results Posted

Study results publicly available

April 18, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 2, 2010

Results QC Date

April 29, 2013

Last Update Submit

April 14, 2017

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaArousal thresholdSedative medicationupper airway

Outcome Measures

Primary Outcomes (1)

  • Apnea Hypopnea Index

    number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \> 30/h = severe

    8 hour In-Laboratory Polysomnogram (PSG)

Secondary Outcomes (3)

  • Arousal Threshold

    8 hour In-Laboratory Polysomnogram (PSG)

  • Nadir Overnight Oxygen Saturation

    8 hour In-Laboratory Polysomnogram (PSG)

  • Sleep Duration

    8 hour In-Laboratory Polysomnogram (PSG)

Study Arms (2)

Eszopiclone

ACTIVE COMPARATOR

Eszopiclone 3mg prior to sleep (1 night)

Drug: Eszopiclone

Sugar Pill

PLACEBO COMPARATOR

Sugar Pill (placebo) prior to sleep (1 night)

Drug: Placebo

Interventions

EszopicloneDRUG

3mg tablet once prior to sleep

Also known as: Lunesta
Eszopiclone
PlaceboDRUG

1 placebo capsule prior to sleep

Also known as: sugar pill
Sugar Pill

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Untreated obstructive sleep apnea

You may not qualify if:

  • Nadir SaO2 \<70% on a baseline PSG
  • Medications known to affect either sleep, breathing or muscle activity
  • Major co-morbidities apart from sleep apnea
  • Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital, Division of Sleep Medicine

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Eckert DJ, Owens RL, Kehlmann GB, Wellman A, Rahangdale S, Yim-Yeh S, White DP, Malhotra A. Eszopiclone increases the respiratory arousal threshold and lowers the apnoea/hypopnoea index in obstructive sleep apnoea patients with a low arousal threshold. Clin Sci (Lond). 2011 Jun;120(12):505-14. doi: 10.1042/CS20100588.

    PMID: 21269278RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

EszopicloneSugars

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridinesCarbohydrates

Limitations and Caveats

We excluded patients with blood arterial oxygen saturations \<70% as we wanted to avoid any potential risks associated with this group.

Results Point of Contact

Title
Atul Malhotra
Organization
Brigham and Women's Hospital
amalhotra1@partners.org
6177326488

Study Officials

  • Atul Malhotra, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 13, 2010

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

May 1, 2010

Last Updated

April 18, 2017

Results First Posted

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

published

Locations

US(1)