InsomniaNCT00911053

Melatonin for Circadian Sleep Disorders in the Blind

A study testing Melatonin, Regular Sleep Schedule and Light in people with Insomnia and Blindness, run by Oregon Health and Science University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Insomnia, Blindness, Daytime Sleepiness
What is being tested?: Melatonin, Regular Sleep Schedule and Light
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: Jun 1997to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

blindness for at least one year, verified by an ophthalmologic exam
ability to comply with the requirements of the experimental protocol
competency to sign informed consent
Exclusion criteria (as determined by medical history and/or physical examination):
abnormal heart, liver or kidney function
a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual

Show all 9Show fewer

possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant)
if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health and Science University
Portland, Oregon, 07239

Other trials in United States

About this study

This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). The second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). The third study phase introduces a new independent variable, light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.

Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and Sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

Conditions: Insomnia, Blindness, Daytime Sleepiness
Being tested: Melatonin, Regular Sleep Schedule, Light
Keywords: melatonin, sleep, blindness, blind individuals
Medical subject headings: Sleep Initiation and Maintenance Disorders, Blindness, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MelatoninDrug
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Regular Sleep ScheduleBehavioural
Subjects will maintain a regular sleep schedule of their choosing.
LightBehavioural
Subjects will be exposed to light.

Study groups in NCT00911053
Study group	Role	What they receive
Baseline	No intervention	Not described
Melatonin	Experimental	Subjects will be administered melatonin. Receives: Drug: Melatonin
Light	Experimental	Not described Receives: Behavioral: Light
Regular Sleep Schedule	Experimental	Not described Receives: Behavioral: Regular Sleep Schedule
Longitudinal Monitoring	No intervention	Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
Measured: 1 year

Secondary outcomes (1)

Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 1997Jun 2012

First posted1 Jun 2009 (estimated)
Study startJun 1997
Primary completionJun 2012
Study completionJun 2012

Why it stopped: Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00911053
Sponsor's protocol ID: R01EY018312
Status last verified: Nov 2019
First submitted: 7 May 2009
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Melatonin for Circadian Sleep Disorders in the Blind
ClinicalTrials.gov ID: NCT00911053
Acronym / sponsor ID: R01EY018312
Conditions: Insomnia, Blindness, Daytime Sleepiness
Keywords: melatonin, sleep, blindness, blind individuals
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Enrolment: 59 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: Jun 1997
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 1 Jun 2009 (estimated)
Results: Posted 27 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Baseline	No intervention	–
Melatonin	Experimental	Drug: MelatoninSubjects will be administered melatonin.
Light	Experimental	Behavioral: Light
Regular Sleep Schedule	Experimental	Behavioral: Regular Sleep Schedule
Longitudinal Monitoring	No intervention	–Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

blindness for at least one year, verified by an ophthalmologic exam
ability to comply with the requirements of the experimental protocol
competency to sign informed consent
abnormal heart, liver or kidney function
a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual

Key exclusion criteria (0 listed)

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
MelatoninMelatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.	Drug	Melatonin
Regular Sleep ScheduleSubjects will maintain a regular sleep schedule of their choosing.	Behavioural	Regular Sleep Schedule
LightSubjects will be exposed to light.	Behavioural	Light

Primary outcome

Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
Time frame: 1 year

1 secondary outcome

Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor.
Time frame: 1 year

Results and safety

Results posted to the registry on 27 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baseline	0	0
Melatonin	0	0
Light	0	0
Regular Sleep Schedule	0	0
Longitudinal Monitoring	0	0

Primary outcome: Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.

Time frame: 1 year

Population analysed: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Baseline	0 of 0	0 of 0
Melatonin	0 of 0	0 of 0
Light	0 of 0	0 of 0
Regular Sleep Schedule	0 of 0	0 of 0
Longitudinal Monitoring	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Analyses were not completed because a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

Recruiting
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Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Recruiting
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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.

Alfred Lewy, MD, PhD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin, Regular Sleep Schedule and Light in people with Insomnia and Blindness, run by Oregon Health and Science University at 1 site in United States.

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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 27 Nov 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion. (time frame: 1 year). 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 NCT00911053.

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 27 Nov 2019.