on sleeplessness in the elderly population – a systematic review

The effect of exogenous melatonin on sleeplessness in the elderly population: a systematic review

Review question
Does the use of exogenous melatonin effect sleeplessness in the elderly population?

Searches
The author designed the search strategy, with the consultation of a medical librarian, and will carry out the searches.

Electronic searches
The following databases will be searched without language or date restrictions:

1. Ovid MEDLINE
2. Ovid EMBASE
3. Cochrane Central Register of Controlled Trials (CENTRAL)
4. PubMed
5. Scopus
6. PsycINFO

The author will also search ClinicalTrials.gov, the ISRCTN (www.isrctn.com) registry and the International Clinical Trials Registry platform (www.who.int/ictrp/en).

Searching other resources – Reference lists: We will screen the reference lists of all included studies and relevant systematic reviews to identify additional studies missed from the original electronic searches (for example unpublished or in-press citations).

Types of study to be included
Only randomized controlled trials will be included to assess the effects of the exogenous melatonin.

Condition or domain being studied
Sleeplessness, exogenous melatonin

Participants/population
Adults aged 65 and over

Intervention(s), exposure(s)
Exogenous melatonin, no dosage or form limitations

Comparator(s)/control
Placebo

Context
Studies in hospital or community

Main outcome(s)
Sleep quality as assessed by Sleep onset latency, Total sleep time, Wake after sleep onset and sleep efficiency.
These outcomes may be measured objectively with actigraphy and polysomnography and subjective sleep quality may be measured using sleep diaries and visual scales.

Additional outcome(s)
None

Draft search

Search concept 1 Search concept 2 Search concept 3 Search concept 4
Elderly
Sleeplessness Melatonin RCT

Medline (OvidSP):

# ▲
Searches Results
1 exp Aged/ (MeSH search for over 65s) 3023378
2 Geriatrics/ or Geriatric Assessment/ (MeSH search for geriatrics) 55038
3 (elder* or geriatric* or (old* adj2 (people or person? or adult? or men or male? or women or female? or patient?)) or veteran?).tw,kw. (Keyword search for elderly) 686603
4 1 or 2 or 3 (Combination of above) 3374439
5 exp Sleep Wake Disorders/ (MeSH search for sleep disorders) 86074
6 (insomnia? or sleepless*).tw,kw. (Keyword search for sleeplessness) 20890
7 (sleep adj2 disorder?).tw,kw. (Keyword search for sleep disorders) 15947
8 5 or 6 or 7 (Combination of above) 100879
9 Melatonin/ (MeSH search for melatonin) 19095
10 melatonin.tw,kw. (Keyword search for melatonin) 23653
11 9 or 10 (Combination of above) 25334
12 randomized controlled trial.pt. 495639
13 controlled clinical trial.pt. 93449
14 randomized.ab. 462556
15 placebo.ab. 203220
16 drug therapy.fs. 2161472
17 randomly.ab. 322828
18 trial.ab. 485825
19 groups.ab. 1982955
20 12 or 13 or 14 or 15 or 16 or 17 or 18 or 4582257
21 exp animals/ not humans.sh. 4648908
22 20 not 21 19 (Lines 12-22 is the Cochrane filter for RCTs) 3968997
23 4 and 8 and 11 and 22 (Final combination of all 4 concepts) 294

Combine with:

Data extraction (selection and coding)
Selection of studies:
The author and a graduate student reviewer will independently evaluate the titles and abstracts of all reports identified by the electronic search, studies not satisfying the inclusion criteria will be eliminated. Copies of the remaining studies will be obtained for full text review.
The reviewers will independently read these full articles to finalise a list of relevant included studies. In the event of disagreement, the supervisor will adjudicate. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart will be included showing the status of identified studies.

Data extraction and management:
The author and a graduate student reviewer will independently extract data using a data extraction form adapted for this review, the reviewers will check for agreement before entering the data into Review Manager. The following information will be used: Authors, Year of Publication, Place of Publication, Type of Study, Sample Size,Gender Split, Age, Dosage and Details of Melatonin Regime, Clinical outcomes, Type of Statistical analysis.

Risk of bias (quality assessment)
The reviewers will independently assess each study for risk of bias using criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. The following bias domains will be assessed. Any disagreements will be resolved by discussion between reviewers and where necessary a third reviewer.

• Random sequence generation (checking for possible selection bias). We will assess the method used to generate the allocation sequence.

• Allocation concealment (checking for possible selection bias). The method used to conceal allocation to interventions prior to assignment determines whether intervention allocation could have been foreseen in advance of, or during, recruitment, or changed after assignment.

• Blinding of participants and personnel (checking for possible performance bias). We will assess any methods used to blind the participants and personnel from knowledge of which intervention a participant received.

• Blinding of outcome assessment (checking for possible detection bias). We will assess any methods used to blind the outcome assessors from knowledge of which intervention a participant received.

• Incomplete outcome data (checking for possible attrition bias due to the amount, nature, and handling of incomplete outcome data).

• Selective reporting (checking for possible reporting bias). We will assess if all planned outcomes in the protocol or methods were also reported in the results.

Strategy for data synthesis
Data will be synthesised using the Review Manager (RevMan 5.3) computer program. All measures will be reported with 95% confidence intervals. Data will be presented in Forest plots and described in the text. Characteristics of included articles will be presented in tables.

Analysis of subgroups or subsets
If sufficient studies are available, we will perform subgroup analyses on subsets of age (65-74, 75-84, 85+), Dementia and other medically relevant co-morbidities.

Organizational affiliation of the review
University of Oxford

Type and method of review
Systematic review

Funding sources/sponsors
None

Conflicts of interest
None known

Language
English

Country
United Kingdom

Stage of review
Review ongoing